Many organizations that manufacture devices and products for distribution and use in the United States are required to register with the U.S. Food and Drug Administration on an annual basis. Some of this registration information is available to the public – but not all. For example, although food manufacturers are required to register with the FDA, the public is not entitled to their registration information.
Finding the FDA Registration Number
You can find publicly-available manufacturer registration numbers assigned by the FDA by searching the FDA’s public databases. Each database uses different search queries, such as the establishment name, owner/operator name, and proprietary name of the product or product code. For the FDA manufacture registration number for animal drug products; human drug products; and vaccines, blood and biologics, such as human cells, tissue and cellular and tissue-based products, visit the FDA’s Drug Establishments Current Registration Site at http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm. For medical devices, visit Establishment Registration & Device Listing at http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfRL/rl.cfm. Other valuable information can be discovered using FDA's other searchable databases, which can be found on the Search Databases page http://www.fda.gov/ForIndustry/FDABasicsforIndustry/ucm234631.htm.
- U.S. Food and Drug Administration: Who Must Register, List and Pay the Fee
- U.S. Food and Drug Administration: Establishment Registration & Device Listing
- U.S. Food and Drug Administration: Registration and Listing
- U.S. Food and Drug Administration: Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition)
- U.S. Food and Drug Administration: Search Databases
- U.S. Food and Drug Administration: Drug Establishments Current Registration Site