US FDA Registration Services

Service Details:

US FDA Registration Services Food and Drug Administration (FDA or US FDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, bio pharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED) and veterinary products.

Foreign Food Facility Inspection Program

The US FDA is increasing the number of routine inspections worldwide of foreign food facilities under the jurisdiction of the FDA that export to the United States (processors/manufacturers, packers/repackers, and holders of foods). This increase is mandated based on new requirements included in the FDA Food Safety Modernization Act (FSMA), as enacted by the U.S. Congress and signed into law by the President on January 4, 2011. FDA is also taking similar efforts with regard to domestic facilities to ensure that the U.S. food supply is safe.

Foreign food facility inspections are designed to:

Identify potential food safety problems before products arrive in the United States.

Determine the compliance status of facilities to FDA’s requirements and food safety standards.Help the agency make admissibility decisions when food products are offered for importation into the United States.

Help ensure that food products under FDA’s jurisdiction meet U.S. requirements under the Federal Food, Drug, and Cosmetic Act.

Which products does FDA regulate:

Foods:Safety of all food products (except for most meat and poultry products, which are regulated by the U.S. Department of Agriculture)

Labelling

Bottled water

Food additives

Infant formulas

Dietary Supplements:

Human Drugs:

Product approvals

OTC and prescription drug labeling

Drug manufacturing standards

Vaccines, Blood Products, and Other Biologic:

Product and manufacturing establishment licensing

Safety of the nation's blood supply

Research to establish product standards and develop improved testing methods

Medical Devices:

From simple items like tongue depressors, to complex technologies such as heart pacemakers

Premarket approval of new devices

Manufacturing and performance standards

Tracking reports of device malfunctioning and serious adverse reactions

Electronic Products:

 

Products that give off radiation, such as microwave ovens and X-ray equipment

Radiation safety performance standards for microwave ovens, television receivers, diagnostic

X-ray equipment, cabinet x-ray systems (such as baggage x-rays at airports), laser products

Ultrasonic therapy equipment, mercury vapour lamps, and sunlamps

Accrediting and inspecting mammography facilities

Cosmetics:

Safety

Labelling

Veterinary Products:

Livestock feeds

Pet foods

Veterinary drugs and devices

Veterinary biologic not regulated by USDA are considered new animal drugs.

Service Details:

CDG provide US FDA Registration in Delhi.

US FDA Registration is required for your product ? Understanding US FDA Registration Requirements, a complete guidance for US FDA compliance.

 

The appointment of an agent is a mandatory requirement for any foreign company wishing to market their products within the United States. CDG can arrange FDA agent, as well as offering a suite of regulatory compliance services to help you through the FDA registration process and other FDA compliance services. Our FDA consultancy can deliver support to enable you to market your food and dietary supplements. We can provide complete assistance for  understanding FDA requirements  for  your products, facility registration, Process Filing for Acidified and Low-Acid Canned Foods (SID), food and dietary supplement labelling review, and FSVP related services.
CDG is an experienced US FDA consulting firm, with an established base of global built over the last twenty years.

Our expertise spans the breadth of compliance services required to market FDA-regulated products, including food, dietary supplement labeling, drugs, medical devices, and cosmetic labeling. We are a leading service provider of  US Agent for FDA-regulated industries and a US agent for drug companies. We offer complete assistance to meet FDA regulatory compliance requirements.

Specifically, if FDA determines that food manufactured, processed, packed, received, or held by a registered food facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, FDA may by order suspend the registration of a facility that:

Created, caused, or was otherwise responsible for such reasonable probability; or

Knew of, or had reason to know of, such reasonable probability; and packed, received, or held such food.

Our services for drug companies include U.S Agent service, Assistance for ANDA submission process, IND, NDA, NADA and drug registration, NDC number, listing services self-identification, eCTD publishing services  & complete assistance to meet FDA requirements. For food and dietary supplement companies, we offer U.S Agent, FSVP agent, Registration, Labeling review, FSVP assistance, FDA SID number, food facility registration services, and other FDA compliance services. For medical devices, we offer U.S Agent services, FDA registration, and listing, as well as UID submission, medical device registration services, and other services for device approval.

In the past 10 years, we have developed experience and understanding of the knowledge and skills needed to address a wide variety of regulatory issues. This means that we can offer solutions that add value, saving you both money and time. We believe in a transparent approach to business, and always put our customers at the center of our work. We strive to achieve excellent customer satisfaction through superior services.

CDG offer the lowest guaranteed fees for quality services. Our charges are disclosed upfront, and there are no hidden costs or increased annual fees.

CDG is one of the top  FDA consultants and US Agent service providers.

Service Details:

The FDA Requirement for each type of registration is different, for food facility the FDA registration number for the manufacturer is mandatory and will get the registration number immediately after the registration is complete. But for Drug and Medical device establishments the FDA registration number is not mandatory, but the establishments must complete the registration. It may take 90 days or more for FDA to assign registration number for drug and medical device establishments. FDA will not issue a Registration Certificate after completing food, drug, medical device, cosmetic, or blood establishment registrations.

FDA Food Safety Modernization Act (FSMA) & Foreign Supplier Verification Programs (FSVP)

 The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.  

The U.S. Food and Drug Administration (US FDA) is responsible for assuring that food sold in the United States is safe, wholesome and properly labeled. This applies to food produced domestically, as well as food from foreign countries. The Federal Food, Drug, and Cosmetic Act (FD and C Act) and the Fair Packaging and Labeling Act are the Federal laws governing food products under US FDA jurisdiction.

Responsibilities of a US FDA Agent

???The US FDA Agent must either reside in the US or maintain a place of business in the US. The US FDA Agent cannot use a post office box as an address. The US FDA Agent cannot use just an answering service. They must be available to answer the phone or have an employee available to answer the phone during normal business hours.

The responsibilities of the US FDA Agent are limited and include:

Assisting FDA in communications with the foreign establishment.

Responding to questions concerning the foreign establishment''s devices that are imported or offered for import into the United States.

Assisting FDA in scheduling inspections of the foreign establishment.

If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the US FDA Agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.

CDG offer you a level of service that exceeds your expectations, whether you''re looking for a facility registration or a complete review of label design.

???We thank you for taking time to browse through our site. We hope you find useful information for you here: a list of the services we offer, contact information, specially-selected articles and much more.

CDG''s top priority is providing outstanding customer service. We pride ourselves on responding promptly to clients’ needs and providing exceptional individual and business advice and services.

Please contact us without hesitation if you have questions. Give us a call or drop us an email for more information about your need, or to make suggestions for what you''d like to see on our website. We look forward to working with you soon!

Service Details:

The Bio-terrorism Act requires US FDA registration for domestic and foreign food facilities, that manufacture, process, pack, or hold food for human or animal consumption in the U.S. Owner, operator, or agent in charge of domestic or foreign food facility is required to register their facility with the US FDA. Domestic facilities require FDA registration whether or not food from the facility enters interstate commerce. Foreign food facilities that manufacture/process, pack, or hold food also require US FDA registration unless food from that facility undergoes further processing (including packaging) by another foreign food facility before the food is exported to the U.S. However, if the subsequent foreign food facility performs only a minimal activity, such as putting on a label, both food facilities require US FDA registration. Acidified and law-acid food manufacturers require FDA food canning establishment (FCE) registration also. The dietary supplement manufacturers also require US FDA registration.

 

The US FDA food facility registration was a one-time registration process till FY 2012. The new FDA Food Safety Modernization Act (FSMA) requires Biennial Registration Renewal for domestic and foreign Food Facilities. Previously registered facilities should renew the registration between October 1 and December 31 of each even-numbered year starting from the year 2012. If any of the mandatory information in the registration changes, the registered food facility must update the registration within 60 days with US FDA. The registered food facility must cancel the US FDA registration within 60 days, if the facility stop or ceases the operation. Previously registered food facilities that does not have US FDA registration information does not require re-registration such facilities can contact US FDA to obtain registration information. Every foreign food facility must have a U.S. FDA Agent who acts as the domestic communications representative for that facility. Foreign facilities must provide the US FDA agent information at the time of FDA registration, and must update the FDA registration information if the facility changes the US FDA agent

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies.

To carry out certain provisions of the Bioterrorism Act, FDA established regulations requiring that:

Food facilities register with FDA, and

FDA be given advance notice on shipments of imported food.

These regulations became effective on December 12, 2003.

The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), in relevant part, to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States submit additional registration information to FDA, including an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Section 415 of the FD&C Act, as amended by FSMA, also requires food facilities required to register with FDA to renew such registrations every other year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances

 

CDG is a leading US FDA registration company in Pune

Service Details:

To comply with the FDA food regulations, all ‘Food Facilities’ involved in the production, processing, storage, or packing of food intended for human or animal consumption must register with the FDA. Foreign companies must do this via a U.S. Agent. CDG can support your business in registering Food Facilities. We also provide a full U.S. Agent service for our foreign companies.

Food

Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA.

The U.S. Food and Drug Administration (FDA) hosted a stakeholder call on Wednesday, March 18th at 3:45 p.m. ET to discuss food safety and food supply questions related to Coronavirus Disease 2019 (COVID-19). FDA provided an overview of current activities, respond to stakeholders’ concerns identified in recent days, and highlight important FDA resources in response to COVID-19 pandemic. 

US FDA agent may be a private company or an individual that resides in the U.S. and, as such, is subject to U.S. legislation. Foreign businesses must provide details about their US FDA agent, including their registered address and telephone number. The FDA registration agent acts as an intermediary between the FDA and the foreign establishment. The FDA contacts the U.S. Agent directly in the case of any updates relating to registration to approval. With our expert team of safety consultants, we dedicate to ensuring the safety of consumers around the world. As we always strive to provide a wide variety of quality resources and tailored solutions to each of our clients, we still consider your unique needs. Confidentiality and quality are our top priorities.

FDA US Agent (FDA Agent)

???Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (FDA US Agent or FDA Agent) for that establishment.

Information about a foreign establishment’s US FDA Agent is submitted electronically using the FDA Unified Registration and Listing System (FURLS system) and is part of the establishment registration process. Each foreign establishment may designate only one US FDA Agent. The foreign establishment may also, but is not required to, designate its U.S. agent as its official correspondent. The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the US FDA Agent.

The US FDA Agent identified will be required to complete an automated process to confirm that they have agreed to act as the U.S. agent. The automated process will forward an email verification request to the FDA US Agent. They will be requested to confirm her/his consent to act as a representative/liaison on behalf of the foreign establishment. If the US FDA Agent denies consent (or does not respond within 10 business days), the Official Correspondent/Owner Operator of the foreign establishment will be notified and must designate a new FDA US Agent to satisfy the regulatory obligation.

CDG is a industry leader for ''US FDA Registration Services in India''. ''US Food Facility Registration'' is our expertise though we do provide US FDA registration service in other product groups also. We may also service as authorised agent for US FDA. So if you have any query regarding US FDA Registration in India please contact CDG.

Service Details:

All enterprises involved in the processing of food, drugs and cosmetics must complete the US FDA Registration if they wish to enter the US market. U.S. Food and Drug Administration (US FDA) has mandated this requirement. All foreign organizations must name a US Agent when registering their companies.

Business owners and their places of activity, so-called establishments or facilities, engaged in any activity which affects the quality of the product such as repacking, re-labeling, storage, or production in any of the FDA regulated industries must REGISTER with the FDA.

We Provide FDA Registration Services To Below Sectors:

FOOD,BEVERAGE OR DIETARY SUPPLEMENTSDRUGSCOSMETICSMEDICAL DEVICES

One of the most basic requirements for selling FDA-regulated products is to make sure they are properly registered and sometimes listed with the FDA. The FDA requires food facilities renew their registration every even-numbered year, and any medical device or drug facility must be registered and listed annually. It is a common misconception that both being registered and listed is just filling out a few forms. FDA uses online systems for these submissions. These systems involve huge amounts of technical validation, and often require specific information or formats in order to accept submissions.

US FDA Registration is a mandatory requiremnet to place your products in USA. US FDA Registration is given under US bio-terrorism act. After registration you are allotaed  a registration number which is used bu US custom authority & other concerned authorities in USA to established your genuine identity as a suppliers to USA. US FDA registration is given in many categories. Most prominent categories are : US FDA Registration for Food, US FDA Registration for cosmetics, US FDA Registration for drugs, US FDA Registration for medical devices. Appart fro these US FDA Registration can also be obtained for packaging materials, utensils & some other product categories.

US FDA Registration Services

CDG is considered as a one stop solution to provide hassle-free US FDA Certification Services / US FDA Registration Services. These services are highly trusted by most of the customers. Our professionals make sure to render these services in strict compliance with the industry standards and norms. These professionals undertake all the certifications responsibilities in an organized manner. Moreover, we make sure to offer these services within the committed time frame in order to meet the requirements of the customers.

CDG offer US FDA certification services in Delhi, India. We are US FDA certification agency, which provide services in different part of India.

CDG Certification ltd is a globally recognized FDA Registration certification provider.  The US Food and Drugs Administration (US FDA) is responsible for assuring that food sold in the United States safe, wholesome and properly labeled. This applies to food produced domestically, as well as food from foreign country. The federal food, Drug and cosmetics Act (FD and C Act) and the fair packaging and labeling Act are federal laws governing the food products under the us FDA Jurisdiction.

 

CDG is a leading US FDA Registration Company in Bangalore.

Additional Information:

• Delivery Time: 7 days

Service Details:

CDG is a regulatory compliance company specializing in the food, beverage, dietary supplement, alcoholic beverage, medical device and cosmetic industries.

Our top priority is providing outstanding customer service. We pride ourselves on responding promptly to clients’ needs and providing exceptional individual and business advice and services.

CDG is a leading organization of the industry, dedicatedly engaged in offering an optimum quality array of FDA Certification Services for our esteemed customers. We help companies to achieve US FDA registration for exporting their products to the USA. Our service is rendered by our talented professionals as per the industry quality standards.  

Companies can export or import products to or from the United States as long as the facilities that produce, store, or otherwise handle them are registered with the U.S. Food and Drug Administration (U.S. FDA), and prior notice of incoming shipments is provided to the FDA.

CDG assists companies around the world, including manufacturers of hand sanitizers,  N95 respirators and other COVID-19 (Coronavirus) personal protective equipment (PPE) covered by Emergency Use Authorizations (EUAs) .

US FDA agent may be a private company or an individual that resides in the U.S. and, as such, is subject to U.S. legislation. Foreign businesses must provide details about their US FDA agent, including their registered address and telephone number. The FDA registration agent acts as an intermediary between the FDA and the foreign establishment.

The US FDA Agent identified will be required to complete an automated process to confirm that they have agreed to act as the U.S. agent. The automated process will forward an email verification request to the FDA US Agent.

We believe in a transparent approach to business, and always put our customers at the center of our work. We strive to achieve excellent customer satisfaction through superior services.

The Bio-terrorism Act requires US FDA registration for domestic and foreign food facilities, that manufacture, process, pack, or hold food for human or animal consumption in the U.S.

It is a program that importers covered by the rule must have in place to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the suppliers food is not adulterated and is not misbranded with respect to allergen labeling. certain categories of imported food are not covered by FSVP.

Just in case you feel the need to switch U.S. Agent, we make the process easy. Get the better service your company deserves.

 Other Details:

Flexible approach

Use advanced tools and technologies

Crystal clear dealings

Timely executed

CDG is one of the top  FDA consultants and US Agent service providers.

Please contact us without hesitation if you have questions. Give us a call or drop us an email for more information about your need, or to make suggestions for what you''d like to see on our website. We look forward to working with you soon!

Service Details:

The food facility registration and prior notice helps US FDA with information on the origin and distribution of food products and thereby aid in the detection and quick response to actual or potential threats to the U.S. food supply. Registration information also helps US FDA to notify the food establishment that may be affected by the actual or potential threat. The US FDA registration statistics shows 171,552 domestic registrations and 278,307 foreign registrations as of July 19, 2012.

 

CDG provides assistance in US FDA food facility registration and helps to comply with FDA bioterrorism act requirements. LMG also provides US FDA Agent service for foreign food facilities. Please note US FDA does not issue a certificate of registration, nor does the US FDA recognize a registration certificate issued by third party, but the US FDA issue a registration number for each registered food facility, FDA registration number does not denote the US FDA approval of the facility.

The Food and Drug Administration Amendments Act (FDAAA) of 2007 requires that all registration and listing information (Annual, Initial or Updates) be submitted electronically unless FDA grants a waiver.

Waivers

The law requires that all registration and listing information be submitted electronically unless FDA grants a waiver. To apply for a waiver from submitting your registration and listing information electronically, please submit your request with a complete explanation of why you cannot submit your information electronically.

 

The registration of a medical device establishment is a two-step process. First you must pay the annual registration user fee. Once you have paid the fee, you can then complete the registration process. Your registration is not considered complete until you have paid your annual registration user fee, submitted your registration and listing information electronically, and received e-mail notification from FDA that all requirements have been met.

US FDA Agent is a mandatory requirement for Foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. The US FDA agent must either reside in the U.S. or maintain a place of business in the U.S. US FDA agent cannot use a post office box as an address. US FDA agent must be available to answer the phone or have an employee available to answer the phone during normal business hours. The FDA agent acts as a communications link between US FDA and the food facility for both routine and emergency communications, unless the facility designates a different emergency contact.

CDG is a industry leader for ''US FDA Registration Services in India''. ''US Food Facility Registration'' is our expertise though we do provide US FDA registration service in other product groups also. We may also service as authorised agent for US FDA. So if you have any query regarding US FDA Registration in India please contact CDG.

Additional Information:

• Delivery Time: 5 days

Service Details:

Companies can export or import products to or from the United States as long as the facilities that produce, store, or otherwise handle them are registered with the U.S. Food and Drug Administration (U.S. FDA), and prior notice of incoming shipments is provided to the FDA.CDG assists companies around the world, including manufacturers of hand sanitizers,  N95 respirators and other COVID-19 (Coronavirus) personal protective equipment (PPE) covered by Emergency Use Authorizations (EUAs) .
Just in case you feel the need to switch U.S. Agent, we make the process easy. Get the better service your company deserves. 

Food exporters represent the largest group of our clients because of u.s. consumers’ growing demand for tropical products, spices, and imported gourmet foods. Food companies based in the United States carry out certain processing steps offshore and import products at different levels of processing from their subsidiaries in foreign markets. Facilities that manufacture, process, pack, or store food, beverages, or dietary supplements that may be consumed in the United States must register with the U.S. Food and Drug Administration (FDA). Facilities located outside of the United States must also designate a U.S. Agent for FDA communications.We offer you a level of service that exceeds your expectations, whether you're looking for a facility registration or a complete review of label design.

 

The FDA Food Safety Modernization Act of 2011 mandates the creation of a food safety system in which the focus is on preventing contamination rather than primarily reacting to problems after they occur. The FSMA rules include those that require preventive controls for food facilities that manufacture/process, pack, and hold human and animal foods, and establish science-based standards for produce grown on farms.These rules apply to domestic food producers and those in other countries who export to the United States. The import community will be most impacted by the Foreign Supplier Verification Programs (FSVP) rule, which requires FSVP importers to verify that the food they import meets U.S. safety standards. FSVP importers are required to develop, maintain, and follow an FSVP for each food imported, unless an exemption applies. The goal is to ensure that each food is produced in a manner that provides the same level of public health protection as the preventive controls and produce safety regulations, if applicable, and the food is not adulterated or misbranded with respect to allergen labeling.

We thank you for taking time to browse through our site. We hope you find useful information for you here: a list of the services we offer, contact information, specially-selected articles and much more.

CDGs top priority is providing outstanding customer service. We pride ourselves on responding promptly to clients’ needs and providing exceptional individual and business advice and services.

Please contact us without hesitation if you have questions. Give us a call or drop us an email for more information about your need, or to make suggestions for what you'd like to see on our website. We look forward to working with you soon!

Additional Information:

• Delivery Time: 7 days

Service Details:

CDG is a FDA-regulatory compliance company specialized in helping non-U.S. based companies in the food, beverage, dietary supplement, drug and medical device industries who sell their products into the United States. Under U.S. law, foreign-based food, drug and medical device companies are required to register with the FDA and appoint a "U.S. Agent".We are committed to helping foreign-based companies with their FDA registration questions and issues, and focus our expertise and services EXCLUSIVELY on clients located outside the United States. We maintain legal and regulatory consultants on staff to provide our clients with critical information and updates on FDA activity, the Food Safety Modernization Act, and other relevant U.S. food, drug and medical device regulations.

 

FDA Food Registration (Bioterrorism Act) is required for both domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States. The owner, operator, or agent in charge of a facility, or an individual authorized by one of them, may register that facility.

 

Our Services:

All the Regulatory Registration functions of the Departments of the Indian FDA - CDSCO & NPPA.

The overseas FDA Product Registrations in the major Export destinations of india. The facilitation of an entire range of Clinical Testing studies required for any FDA registration in india and abroad. Food products rank among the most heavily regulated goods in U.S. commerce. All food imported into the U.S. must meet the same requirements for food safety and food labeling as food produced within U.S. borders. These requirements are very complex. U.S. Food Imports shoulders the burden of navigating complex FDA requirements so you don’t have to.

Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d] requires food facilities that are required to register with FDA to renew such registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year.

For foreign companies importing into the United States, a U.S. registration agent is required. A registered agent acts as a registered address of the corporation in the U.S. and provides this registered address for the receipt of service of government filings – and sometimes legal documents - and acts as a liaison for government agencies.

Foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. are required to register with the US FDA and have an FDA US agent. The FDA US agent must either reside in the U.S. or maintain a business in the U.S. The agent must be able to communicate with FDA during normal business hours for routine and emergency communications, unless the facility designates a different emergency contact.

 

Give us a call or drop us an email for more information about your need, or to make suggestions for what you''d like to see on our website. We look forward to working with you soon!

Service Details:

CDG provides you compliance services for US FDA Foreign Supplier Verification Program. The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011.

It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. The FDA FSMA rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals is final, and the first compliance dates begin May 30, 2017. It is a program that importers covered by the rule must have in place to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the suppliers food is not adulterated and is not misbranded with respect to allergen labeling. certain categories of imported food are not covered by FSVP.

These include: Juice, fish, and fishery products subject to and in compliance with FDAs Hazard Analysis and Critical Control Point (HACCP) regulations for those products, and certain ingredients for use in juice and fish and fishery products subject to the HACCP regulations. Food for research or evaluation Food for personal consumption beverages and certain ingredients for use in alcoholic beverages Food that is imported for processing and future export Low-acid canned foods (LACF), such as canned vegetables, but only with respect to microbiological hazards covered by other regulations, as well as certain ingredients for use in LACF products (but only with respect to microbiological hazards). Certain meat, poultry and egg products regulated by the U.S. Department of Agriculture at the time of importation.
CDG will get you ready for FSVP inspection & audits.

FDA Detention of Food products???
The common reasons of FDA food detention:

The food facility is not registered with FDA.

The food labeling does not comply with FDA regulations.

The manufacturer doesn''t appoint a US Agent.

The prior notice is not available or not properly applied.

The food exporter/importer is not registered with FDA.

 

Compliance & Enforcement

 

???

 

To protect public health, the US FDA monitors domestic firms and the foods that they produce. FDA also has multiple initiatives for monitoring imported products and foreign firms exporting to the United States. FDA protects consumers from unsafe foods through:

Research and methods development

Inspection

Sampling

Recall

Seizure

Injunction

Criminal prosecution

Acidified & Low-Acid Canned Foods

FDA Regulations require commercial processors of shelf stable acidified foods and

low-acid canned foods in a hermetically sealed container to be sold in the United

States to register each establishment and file scheduled processes with the FDA

for each product, product style, container size and type and processing method

(21 CFR 108).

A low-acid canned food (LACF) is any food (other than alcoholic beverages) with a

finished equilibrium pH greater than 4.6 and a water activity greater than 0.85,

excluding tomatoes and tomato products having a finished equilibrium pH less than 4.7.

An acidified food (AF) is a low-acid food to which acid(s) or acid food(s) are added and which has a finished equilibrium pH of 4.6 or below and a water activity (aw)greater than 0.85.

Additional Information:

• Delivery Time: 15 days

Service Details:

CDG is a regulatory compliance company specializing in the food, beverage, dietary supplement, alcoholic beverage, medical device and cosmetic industries. Our regulatory compliance specialists have decades of FDA industry and regulatory experience. Committed to maintaining our position as a leading provider of registration and listing services, we strategically focus our knowledge and limit our services. This approach assures that CDG always achieves the highest quality of service and continued client satisfaction.

The FDA requires all domestic and foreign facilities that manufacture, process, pack, or hold food, beverages or dietary supplements for importation or distribution in the United States to register with the FDA. Any imported foods or imported beverages not in compliance with FDA’s food facility registration requirements may be refused by FDA or CBP. Foreign food facilities must designate a U.S. Agent when registering their food facility with the FDA. The U.S. Agent is a person or entity located within, or that maintains an office, in the United States. The U.S. Agent plays the role of the domestic representative for the foreign facility through which all communication with the FDA takes place.Our top priority is providing outstanding customer service. We pride ourselves on responding promptly to clients’ needs and providing exceptional individual and business advice and services.

All commercial processors of low-acid and acidified foods located in the United States and all processors in other countries who export low-acid canned food or acidified food products into the United States must register their processing plants with FDA. Also, manufacturers must file documentation with FDA for each process used in the production of foods subject to these requirements. These submissions are known as a “Process Filing” and each is assigned a unique “Submission Identifier” (SID). Wholesalers, importers, distributors, brokers, etc. are not required to register and file processes. However, they must ensure that processing firms they represent comply with all registration and process filing requirements.

FDA Food & Dietary Supplement Labeling Requirements

???The US FDA has provided guidance for food & dietary supplement labeling Requirements. The guidance represents the FDA''s thinking on the requirement. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. You can contact Willow Glen Consultancy staff to discuss more detail for labeling requirement. You can also contact the FDA staff responsible for implementing this guidance. 

Some of the important events relating to the labeling of dietary supplements include:The Nutrition Labeling and Education Act of 1990 amended the Federal Food, Drug, and Cosmetic Act (the act) in a number of important ways. Notably, by requiring that most foods, including dietary supplements, bear nutrition labeling.

The Dietary Supplement Health and Education Act of 1994 (the DSHEA) amended the act, in part, by defining "dietary supplements," adding specific labeling requirements for dietary supplements, and providing for optional labeling statements.

Please contact us without hesitation if you have questions. Give us a call or drop us an email for more information about your need, or to make suggestions for what you''d like to see on our website. We look forward to working with you soon!

Service Details:

CDG provide FDA registration service to Food, Drug, Medical Device and Cosmetic Companies. FDA registration is a mandatory requirement for Food, Drug, and Medical device establishments. FDA registration for cosmetic establishments and products are voluntary. For foreign establishments, our FDA registration services includes FDA agent service also, which is a requisite to complete the registration. 

If you have a food manufacturing, processing, packing, or holding facility and the food products from your facility is marketing in the USA, you need to register your food facility with FDA. If your facility is outside the USA, you must have a US FDA Agent to successfully complete the registration. Domestic facilities do not require a US Agent to complete the registration.
After successfully completing the registration, FDA will assign an eleven-digit registration number to each facility. This eleven-digit FDA registration number is a prerequisite for issuing the prior notice.

CDG is a leading consulting firm for ''US FDA Registration Services in India''. ''US Food Facility Registration'' is our expertise though we do provide US FDA registration service in other product groups also.

FDA US Agent & registration service:

???The appointment of FDA US Agent is a mandatory requirement for foreign company who wish to sell their food products in the United States.

First time registration, modification, and/or renewal of your Food Facility Registration.Electronic Certificate of Registration.

One year FDA US Agent Service.

Provide documentation for your business partners (suppliers, customers, and importers) when they need to verify your facility registration status.

Apply prior notice to US FDA when requested.

Review food product labeling with FDA requirements when requested.

Compliance & Enforcement

To protect public health, the US FDA monitors domestic firms and the foods that they produce. FDA also has multiple initiatives for monitoring imported products and foreign firms exporting to the United States. FDA protects consumers from unsafe foods through:

Research and methods development

Inspection

Sampling

Recall

Seizure

Injunction

Criminal prosecution

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Service Details:

The FDA Food Safety Modernization Act (FSMA) is transforming the nation’s food safety system into one that is based on the prevention of foodborne illnesses. It will be a system in which the food industry systematically puts in place measures proven effective in preventing contamination.

Keeping food safe to eat is paramount, no matter where it is produced, whether conventional or organic, whether the operation is small, medium or large, whether it’s produce or processed foods.

The FDA has finalized the foundational rules that will implement FSMA, including the Preventive Controls rules for Human and Animal Food, the Produce Safety rule, and the Foreign Supplier Verification Programs (FSVP) rule. There will be extensive outreach to industry to help ensure that everyone who seeks to comply with these rules, whether legally required to or not, understands the new requirements. The compliance dates vary, in part, according to the size of the business.

Food industry training will be an important component of successful implementation. The Produce Safety Rule and the Preventive Controls rules all have training components, although they are not the same for each rule. There will be ample time for farmers and food producers to come into compliance. Compliance dates for the rules are staggered according to the size of the business.

Be prepared for FSMA inspections. Tailored to meet your needs, our FSMA audits are adapted to each site, focus on specific requirements not already covered in your food safety systems, and can include bespoke requirements as well as hazard-specific controls:

• FSMA pre-certification audits to prepare for accredited FSMA certification
• Gap assessments and gap audits
• Food defense (intentional adulteration) audits
  • Compliance audits for intentional adulteration (IA) rule
  • Vulnerability assessment of facilities
• Preventive controls audits
• FSMA addendum audits for GFSI standards
• FSMA Importer Compliance Audits
  • Foreign Supplier Verification Program (FSVP) compliance audits
  • Supplier risk assessments
  • Supplier preventive controls audits
• With FSMA, the food industry is shifting to a proactive culture that focuses on preventing contamination events, rather than reacting after the fact. 
• CDG can help you ensure compliance across your food facilities and supply chain with FSMA audit, testing, training and technical services.

The FDA Food Safety Modernization Act (FSMA) is transforming the nation's food safety system by shifting the focus from responding to foodborne illness to preventing it.

The FDA FSMA rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals is final, and the first compliance dates begin May 30, 2017. ... The FDA is committed to helping importers the FSVP requirements.

The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on Jan. 4, enables FDA to better protect public health by strengthening the food safety system. It recognizes that preventive control standards improve food safety only to the extent that producers and processors comply with them.
Achieve certification and help prepare your organization for FSMA compliance.