FDA Food registration FAQs

Time:2020-03-04 Views:596

1. Who must register? The owner, operator or responsible agent for the production / processing, packaging or storage of human or animal feed consumed in the United States or the domestic or foreign facilities of an individual authorized by him must submit it to FDA by December 12, 2003. Register its facilities. For domestic facilities in the United States, they must be registered regardless of whether the facility enters interstate trade or not. When registering a foreign facility, you must specify an American agent (such as an importer or broker of the facility) who must reside in the United States or have a place of business in the United States.

2. Which organization is a certificate issued by the FDA? A: There is no certificate for FDA registration. If the product is registered with the FDA, the registration number will be obtained. The FDA will give the applicant a reply (signed by the FDA CEO), but without an FDA certificate.

3. Does the FDA require the designated certified laboratory testing? A: The FDA is a law enforcement agency, not a service agency. If someone said they are FDA-certified laboratories, they would at least mislead consumers because the FDA has neither a service-oriented certification body, a public laboratory, or so-called "designated laboratories". As a federal law enforcement agency, the FDA cannot participate in matters such as referees and athletes. The FDA only recognizes the GMP quality of service testing laboratories and issues certificates of conformity, but does not "designate" the public or recommend a particular one or more.

4. Do you need a US agent for FDA registration? A: yes, Chinese applicants must designate American citizens (companies / associations) as their agents when registering with FDA. The agent is responsible for the process services in the United States and is the medium for contacting FDA and the applicant.

Which institutions do not need to register?
Individual private residence, even if can produce / process, package or store food.
Non-bottled water sources and water distribution facilities, such as urban water supply systems
Vehicles only carrying food in the daily transport business
A farm, a facility for harvesting crops and / or breeding animals (including aquatic products) in one place. Cleaning, trimming the surrounding leaves, and cooling of the product are considered part of the harvest. The term "farm" also includes food packaging or storage as long as they are grown, raised or consumed on that farm or other farms of the same owner, and the agency producing / processing food, as long as all such food is spent on that farm or other farms of the same owner.

A restaurant in a hotel, that is, facilities that prepare and sell food directly to consumers, including kennels, kennels and veterinary institutions that provide food directly to animals. Centralized kitchens that provide food to interstate carriers, such as commercial airlines, or centralized kitchens that do not prepare and provide food directly to consumers, are not restaurants provided for in this Law. The main function of retail food facilities, such as non-staple food stores, community deli and roadside food stores, is to sell food directly to consumers; that is, their annual direct sales to consumers are greater than those to other buyers. The production / processing, packaging or storage of food and its main function is to sell food directly to consumers, including facilities for production / processing of food facilities, which are retail food facilities and do not require registration.

Non-profit food facilities, charities that meet the Internal Profit Code 501 (c) (3), charities that either prepare or provide food directly for consumers, or charities that provide food for human consumption in the United States. Examples of non-profit food facilities include the Central Food Bank, porridge shops, and non-profit food delivery services.
For fishing, the fishing boats that transport the fish. These vessels can engage in activities performed on fishing vessels for storage purposes only, such as removal of fish heads, removal of offorgans or freezing, and exemption from registration.

5. Is registration required for all foreign organizations that produce / process, package or store food in the United States? No. If a foreign agency that manufactures / processes, packages or stores food is sent to another foreign institution for further production / processing or packaging before being exported to the United States, only a second foreign institution needs to be registered. However, if the second foreign institution only carries out small processing such as labeling, then both institutions need to register. At the same time, all foreign institutions that pack or store food after the last foreign manufacturer / processor must register.

6. How long does it take to register? Each food facility only needs to be registered once. However, if you change the required registration information, you need to update the registration information appropriately. If the registration information submitted in the past changes, the facility must update the registration information within 60 calendar days after the change, except for the change of the facility owner. If the facilities are different, the former owner needs to cancel the registration information within 60 calendar days after the change, and the new owner resubmits the registration (21 CFR 1.234).

7. Is food FDA registered, product registration or company registration? Register for business. The company corresponds to the FDA registration number. When registering, the relevant food information produced by the company will also be recorded. As long as the food company registers the FDA number, all the food produced by the company can be exported to the United States. Therefore, food companies only need to register once and apply for a FDA registration number.

8. What does it mean to get a FDA registration number? It only indicates that the facility owner is registered with FDA in accordance with this regulation. The specified number does not mean that the facility or its products are approved or approved by FDA.

9. Is the FDA registration information public? It‘s private. Whether it is a list of registration facilities, a registration document submitted under this section, or a registration facility that may show the identity or address of a particular registrant and any relevant information in the submission list, it is in compliance with the Freedom of Information Act (Freedom Information Act (FOIA)), which is not disclosed.

10. What if the facility is not registered? The Federal Food, Drug and Cosmetic Act (Federal Food, Drug and Cosmetics Act) prohibits domestic or foreign facilities that are not registered, updated or cancelled in accordance with FDA regulations. The federal government may bring a civil action in the federal court of an individual who commits a prohibited act in federal court or a criminal action in federal court against an individual suspected of an illegal act. If the owner of the foreign facility, the operator or responsible agent does not register the facility, food imported into the United States from the facility will be detained at the port of entry unless the FDA or Customs and Border Protection (CBP)) requires otherwise. The US Food and Drug Administration plans to issue implementation guidelines on the agency‘s policy of rejecting 801 (m) (1) and withholding of imported food under 801 (m) (1).

11. What information does the food FDA registration contain? The registration contents mainly include: company name, address, contact information, parent company information, emergency contact information, U. S. agent information, production and processing season, business type, product category and registration statement. Should any change in the above information occur, the Company must immediately go through the FDA change procedure, otherwise the FDA will consider fraudulent activities and restrict access of the Company‘s products to the United States.

12. How to apply for FDA registration? Companies can apply online through FDA, or register with a third-party FDA registration service. We recommend that you seek professional third-party FDA registration services for FDA registration. Based on the knowledge and operation of FDA regulations, you can reduce the complexity of your application and ensure that FDA registration is completed as soon as possible. Related services, such as PN advance notice, ensure the smooth passage of food companies through the United States.

13. Is the FDA registration number valid? FDA registration requires that the original registration number be registered and updated every two years, even if registered on time, to ensure that the original FDA registration number is valid.

14. What is the cancellation of the registration? Under the Food, Drug and Cosmetic Act 415 (b), the FDA may order the removal of the facility if it determines that food produced / processed / packaged / received / stored at a facility has a reasonable probability of causing a serious health hazard or death to humans or animals.register. Facility: Responsible party with / reasonable or reasonable probability is known of a reasonable probability and has packaged / received or stored food. The FDA may provide an informal hearing for a registrant applying for a registration revocation order. Unless the FDA and the registrant agree at another time, the hearing may be held as soon as possible but not more than two business days after the revocation order is issued. For the cancellation of a registered facility, no one can import or export food from the United States, provide food for import and export facilities into the United States, nor introduce food from the facility into interstate and intra-state enterprises in the state. America.trade.

The above are answers to frequently asked questions about food FDA registration. You are welcome to contact us to consult us about FDA certification and registration.