U.S. FDA food facility registration is required for all companies that manufacture, process, pack, or store food, beverages, or dietary supplements that may be consumed in the united states. Food facilities located outside the united states must also designate a u.s. Agent for fda communications. The u.s. Agent for fda communications serves a different function than an importer, customs broker or commercial distributor. Fda sends communications to the designated u.s. Agent, including information regarding inspections, often requiring an immediate response. Registrar corp's regulatory specialists will handle a foreign facility's fda communications professionally as a u.s. Agent. the u.s. Fda is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the united states. For devices that are exempt from premarket notification, manufacturers (both domestic and non-u.s.) and initial distributors (importers) of medical devices must register their establishments with the u.s. Fda. the u.s. Fda regulates drug products intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and intended to affect the structure or any function of the body of humans or animals. Registrar corp provides registration, u.s. Agent, and compliance assistance for u.s. And non-u.s. Companies in the drug industry. the u.s. Fda regulates cosmetic products intended for use in the united states and the state of california has imposed additional requirements for cosmetic products intended for use in california. Registrar corp provides registration, ingredient statement filing, and labeling assistance for u.s. And non-u.s. Companies in the cosmetic products industry. Companies shipping products to the united states may find their shipments subject to "detention without physical examination" by u.s. Fda. Products subject to detention without physical examination are held at the port of entry while u.s. Fda performs additional scrutiny, testing, and analysis. Delays from detention without physical examination may be lengthy for businesses anxious to deliver products on schedule. fdas activities in india are to ensure that food and medical products exported from india to the u.s. Are safe, are good quality, and are effective; these efforts include obtaining better and more robust information to help fda officials in the various fda headquarter offices and centers and at the borders make better decisions about products from india that are being developed for the u.s. Market. This includes products being reviewed for marketing authorization in the u.s., and that are already on the u.s. Market. To this end, fda activities in india include: engaging with indian counterpart regulatory authorities to ensure the timely exchange of information regarding clinical trials that are conducted that support marketing applications in the u.s.; partnering with indian counterpart agencies on various bilateral and regional capacity building initiatives; working with regulated product industries in india that wish to export their products to the u.s. To assure their understanding of our standards and expectations regarding fda-regulated products; coordinating and collaborating daily on product quality and safety issues with other u.s. Government agencies that have complementary missions to assess conditions and events in those areas that might have an impact on the safety and quality of fda-regulated products being exported to the u.s.; increased fda inspections of relevant high-risk facilities; and by working with private- and public-sector entities that wish to engage with fda on third-party certification efforts regarding these products.

FDAs activities in India are to ensure that food and medical products exported from India to the U.S. are safe, are good quality, and are effective; these efforts include obtaining better and more robust information to help FDA officials in the various FDA headquarter Offices and Centers and at the borders make better decisions about products from India that are being developed for the U.S. market. This includes products being reviewed for marketing authorization in the U.S., and that are already on the U.S. market. To this end, FDA activities in India include: engaging with Indian counterpart regulatory authorities to ensure the timely exchange of information regarding clinical trials that are conducted that support marketing applications in the U.S.; partnering with Indian counterpart agencies on various bilateral and regional capacity building initiatives; working with regulated product industries in India that wish to export their products to the U.S. to assure their understanding of our standards and expectations regarding FDA-regulated products; coordinating and collaborating daily on product quality and safety issues with other U.S. government agencies that have complementary missions to assess conditions and events in those areas that might have an impact on the safety and quality of FDA-regulated products being exported to the U.S.; increased FDA inspections of relevant high-risk facilities; and by working with private- and public-sector entities that wish to engage with FDA on third-party certification efforts regarding these products. U.S. FDA food facility registration is required for all companies that manufacture, process, pack, or store food, beverages, or dietary supplements that may be consumed in the United States. Food Facilities located outside the United States must also designate a U.S. Agent for FDA communications. The U.S. Agent for FDA communications serves a different function than an importer, customs broker or commercial distributor. FDA sends communications to the designated U.S. Agent, including information regarding inspections, often requiring an immediate response. Registrar Corp's Regulatory Specialists will handle a foreign facility's FDA communications professionally as a U.S. Agent. The U.S. FDA is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. For devices that are exempt from Premarket Notification, Manufacturers (both domestic and non-U.S.) and initial distributors (importers) of medical devices must register their establishments with the U.S. FDA.

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.

We provide fda registration services. The public health security and bioterrorism preparedness and response act of 2002 (the bioterrorism act) requires all non-u.s. Facilities that manufacture, process, pack, or hold food for human or animal consumption in the united states to register with the fda. fda registration has to be carried out according to the specific fda instructions. Contact system today and receive your fda facility registration number without further delay! the bioterrorism act defines foreign facilities as any establishment, structure, or structures under one management at one general physical location, or, in the case of a mobile facility, traveling to multiple locations that manufactures/processes, packs, or holds food for consumption in the united states. Often exporters need to register multiple facilities where food is stored, packed and prepared for shipment cdg is a full-service provider that will quickly and professionally register your facility and/or serve as your u.s. agent registration representative. Upon special request, cdg can also assist in the preparation of prior notices for shipments coming into the usa.

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 dont 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!

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.

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. 

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 mayl also service as authorised agent for US FDA. So if you have any query regarding US FDA Registration in India please contact us.

CDG provides US FDA registration services in Ahmedabad.CDG is a leading organization in US FDA Registration in India.

FDA Certificate

FDA will not issue a registration certificate after completing the registration; also, FDA will not recognize a third-party registration certificate. Most Importers and Shipping companies always ask for an FDA registration certificate or proof of FDA registration from the manufacturer. LMG will issue a certificate of FDA registration to our clients for their records free of cost. Our clients and their customers can verify the certificate on our website.

If you want to export products in the USA, you need to comply with certain US Import and Export Formalities. One such mandatory requirement you need to fulfill is US FDA Certification. It is a basic requirement that you need to export products such as Food, Drugs, Cosmetics, Color Additives, Medical Devices, supplements, and even PPE Kit. Thus, it is important to get a US FDA certificate in India for every exporter exporting these products to the USA. In this article, you will get to know the complete process to get a US FDA Certificate in India.

What is the US FDA certificate in India?

FDA (Food and Drug Administration) is a US Government Agency. It was established under the Federal Food and Drugs Act.

The basic purpose of the US FDA is to protect and manage public health. Furthermore, the FDA works as a regulatory body. So, it ensures public safety by regulating the manufacturing, marketing, and distribution of a variety of products.

Complete process to get US FDA Certificate in India

The FDA has the power to investigate other nations facilities that export food and pharmaceutical items to the US. Food and pharmaceutical facilities operating in India that export goods to the U.S. need to mandatorily follow the FDAs Current Good Manufacturing practices requirements (CGMP) in order to get US FDA Certificate in India. The complete process to get US FDA Certificate in India is as follows:

Easy and Free Consultation with our US FDA Certification Experts for understanding the requirements, eligibility criteria, and document preparation.

Choose a Package and Online Submission of the required documents on our web portal.

Our team will designate a US FDA Agent who is registered in the United States and then submit the application to the US Food and Drug Administration.

FDA Officials visit your manufacturing plant in India

After the FDA Department and US FDA Officials successfully inspect your business and get satisfactory verification, they will approve the import of the drug or any other product and we will deliver your US FDA Certification in India through your preferred online channel.

The United States Food and Drug Administration (FDA or USFDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

CDG Provides US FDA registration services in Chennai.

The United States Food and Drug Administration (FDA or USFDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs, but involves such things as regulating lasers, cellular phones, and condoms, as well as control of disease in contexts varying from household pets to human sperm donated for use in assisted reproduction.

The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services. Robert Califf is the current commissioner, as of 17 February 2022.

The FDA has its headquarters in unincorporated White Oak, Maryland. The agency also has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico. In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.

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.

CDG provides US FDA registration in Kolkata.

FDA Certificate

FDA will not issue a registration certificate after completing the registration; also, FDA will not recognize a third-party registration certificate. Most Importers and Shipping companies always ask for an FDA registration certificate or proof of FDA registration from the manufacturer. LMG will issue a certificate of FDA registration to our clients for their records free of cost. Our clients and their customers can verify the certificate on our website.

If you want to export products in the USA, you need to comply with certain US Import and Export Formalities. One such mandatory requirement you need to fulfill is US FDA Certification. It is a basic requirement that you need to export products such as Food, Drugs, Cosmetics, Color Additives, Medical Devices, supplements, and even PPE Kit. Thus, it is important to get a US FDA certificate in India for every exporter exporting these products to the USA. In this article, you will get to know the complete process to get a US FDA Certificate in India.

What is the US FDA certificate in India?

FDA (Food and Drug Administration) is a US Government Agency. It was established under the Federal Food and Drugs Act.

The basic purpose of the US FDA is to protect and manage public health. Furthermore, the FDA works as a regulatory body. So, it ensures public safety by regulating the manufacturing, marketing, and distribution of a variety of products.

Complete process to get US FDA Certificate in India

The FDA has the power to investigate other nations facilities that export food and pharmaceutical items to the US. Food and pharmaceutical facilities operating in India that export goods to the U.S. need to mandatorily follow the FDAs Current Good Manufacturing practices requirements (CGMP) in order to get US FDA Certificate in India. The complete process to get US FDA Certificate in India is as follows:

Easy and Free Consultation with our US FDA Certification Experts for understanding the requirements, eligibility criteria, and document preparation.

Choose a Package and Online Submission of the required documents on our web portal.

Our team will designate a US FDA Agent who is registered in the United States and then submit the application to the US Food and Drug Administration.

FDA Officials visit your manufacturing plant in India

After the FDA Department and US FDA Officials successfully inspect your business and get satisfactory verification, they will approve the import of the drug or any other product and we will deliver your US FDA Certification in India through your preferred online channel.

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.

CDG Provides US FDA registration in Pune.

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.

US FDA Certificate

The US FDA Certificate generally means that companies registered with the US food and drug administration are often asked by their customers and suppliers to verify their registration number and registration validity date especially in the case of food manufacturers & exporters

Manufacturers, Exporters, and Traders across the globe are curious to have the word FDA Certified in the name of the company. But this is not possible! The FDA will not issue any kind of certificate to any organization other than domestic manufacturing companies.

US FDA Certificate for Export

Domestic firms exporting products from the United States are often asked by their foreign customers or foreign governments to supply an FDA certification for products regulated by the food and drug administration. A US FDA Certificate is a document prepared by the U.S. Food and Drug Administration, containing information about a products regulatory or marketing status.

We are US FDA agents and regulatory consultants having offices in the USA, Germany, and India.

We issue certificate which serves as a third-party confirmation of your registration status.

The third-party FDA Certification will not have any legal validity, nor does the US FDA recognizes this certificate of registration issued.

FDA Registration

FDA registration is the basic requirement for domestic and foreign establishments that manufacture or market food, drug, API, or medical device in the USA. FDA registration is not mandatory for cosmetic establishments, but they can participate in FDA voluntary cosmetic registration program (VCRP).

US FDA Agent

All foreign Establishments must identify a US FDA Agent while in the registration process. This is a mandatory requirement, and without US FDA Agent, the registration cannot be completed. Liberty Management Group Ltd provides US FDA Agent service to foreign food, drug, API, and medical device establishments.

FDA Registration Renewal

All Drug, API, and Medical Device establishments registered with FDA must renew their registration annually between October 1st and December 31st. Food facilities must renew their FDA registration between October 1st and December 31st of every even-numbered year (once every 2 years). The FDA may consider the products of companies that do not comply with FDA renewal requirements as misbranded and may lead to FDA detention of your products.

FDA Certification

FDA Registration or FDA registration number does not denote FDA certification or FDA approval of your facility or products. Any representation of the FDA registration number on the product label or labeling which implies FDA certification or FDA approval of a facility or product is misleading and may cause misbranding of the product.

CDG provides US FDA registration services in Hyderabad.

What is the US FDA certificate in India?

FDA (Food and Drug Administration) is a US Government Agency. It was established under the Federal Food and Drugs Act.

The basic purpose of the US FDA is to protect and manage public health. Furthermore, the FDA works as a regulatory body. So, it ensures public safety by regulating the manufacturing, marketing, and distribution of a variety of products.

Complete process to get US FDA Certificate in India

The FDA has the power to investigate other nations facilities that export food and pharmaceutical items to the US. Food and pharmaceutical facilities operating in India that export goods to the U.S. need to mandatorily follow the FDAs Current Good Manufacturing practices requirements (CGMP) in order to get US FDA Certificate in India. The complete process to get US FDA Certificate in India is as follows:

Easy and Free Consultation with our US FDA Certification Experts for understanding the requirements, eligibility criteria, and document preparation.

Choose a Package and Online Submission of the required documents on our web portal.

Our team will designate a US FDA Agent who is registered in the United States and then submit the application to the US Food and Drug Administration.

FDA Officials visit your manufacturing plant in India

After the FDA Department and US FDA Officials successfully inspect your business and get satisfactory verification, they will approve the import of the drug or any other product and we will deliver your US FDA Certification in India through your preferred online channel.

The United States Food and Drug Administration (FDA or USFDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs, but involves such things as regulating lasers, cellular phones, and condoms, as well as control of disease in contexts varying from household pets to human sperm donated for use in assisted reproduction.

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 provides US FDA registration services in Kochi.

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.

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.

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.

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!

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.