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FDA Registration

FDA Registration

What is FDA Registration?

Establishments or facilities that manufacture, label, package, or perform certain other operations on foods, drugs, medical devices, tobacco, or biologics are required to register with FDA. A registered facility receives a unique registration number from FDA which FDA uses to identify the firm for inspections, exams, screening of imported products, and other activities. Registration is also used to help FDA locate the source of any problem such as any harmful contamination of the products to prevent further spread or recurrence of the problem.

Information needed for registration includes the full legal name and address of the businesses, contact information (and US agent contact for foreign establishments), information regarding its products, and other information. The registration requirements and the information that needs to be submitted vary depending on the type of commodity.

Once my establishment is registered, it is considered FDA-approved? If not, what do I need to do for FDA to approve it?

Registration of an establishment does not constitute an FDA approval of the establishment. FDA does not approve establishments. FDA uses the registration information to keep track of its regulated facilities, locate the facilities in the event a problem is found in their products, and to schedule routine inspections of the facilities to determine if they are complying with FDA regulations such as good manufacturing practices (GMPs). FDA may take enforcement action against facilities/establishments if FDA finds any violations during an inspection, but FDA does not approve the facility or establishment.

Do foreign facilities need to register?

Foreign facilities are subject to the same registration requirements that FDA places on domestic facilities. For example, FDA requires both foreign and domestic facilities that manufacture, prepare, pack, or hold food for consumption in the United States to register with FDA as food facilities. As with domestic firms, FDA uses the registration information to keep track of regulated facilities and schedule inspections. FDA does routinely inspect facilities in foreign countries. Foreign facilities that do not pass an FDA inspection may be placed on an import alert under which FDA may automatically detain their shipments without requiring physical exam.

Are importers required to register?

For foods, if the importer engages in any manufacturing, processing, preparing, packing, labeling, or holding of the food for consumption in the Unites Stated, the importer must register as a food facility with FDA.

For drugs, if the importer performs any manufacturing, repacking, relabeling, or salvaging operations for distributing the drug in the United States, then the importer must register as a drug establishment with FDA.

For medical devices, if the importer is the initial importer of the devices, then the importer must register as a medical device establishment with FDA. Furthermore, if the importer relabels the product, is the specification developer, further processes the device, or sterilizes the device, then the importer must register as well.

How long does FDA Registration take?

FDA Specialist can usually complete the registration for a company within 2-3 business days if provided all the necessary information and the company completes all required steps. The timeframes for certain products may also depend on how quickly FDA can process the applications.

Who must register with FDA?

For products intended to be distributed in the United States, FDA requires registration for domestic and foreign establishments that:

  • Process, prepare, pack, or hold food
  • Manufacture, import (initial importer), or sterilize medical devices, or develop specifications for medical devices, or perform other operations related to the processing, development, or distribution of medical devices
  • Manufacture, repack, relabel, or salvage drugs
  • Manufacture tobacco products

Who submits FDA Registration?

The company may submit the registration application to FDA or authorize a third-party agent such as FDA Specialist, LLC to register its establishment or facility. For foreign establishments, the US agent the company assigns for the registration may submit the registration application.

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Richard Chiang worked for the FDA for 13 years beginning as a field investigator and entry reviewer and later worked at the FDA’s headquarters Center for Food Safety and Applied Nutrition (CFSAN)

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richard@fdaspecialist.com

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*FDA Specialist, LLC is a private consulting company and is in no way affiliated with the United States Food and Drug Administration or other government agency.