FDA Registered Facilities

An FDA registered facility is a manufacturing, processing, packing or holding facility that is required to register with the United States Food and Drug Administration (FDA).

Companies register so the FDA knows that facilities are aware of their regulatory obligations and to help the FDA identify and track the location of the facilities that manufacture, process, pack, or hold food & other items sold in the USA.

The FDA registration process involves submitting information about the facility, its products, and its ownership to the FDA. Once a facility is registered, it is subject to periodic inspections by the FDA to ensure that it continues to meet the regulatory requirements.

Facilities which manufacture, process, pack, or hold food, drugs, medical devices, or cosmetic products that are sold in the United States are required to register with the FDA, regardless of where the services or products are produced. This applies to both domestic and foreign facilities.

There are some exemptions to the registration requirement, such as facilities that only manufacture, process, pack, or hold food for animals or facilities that only engage in certain low-risk activities. However, even facilities that are exempt from the registration requirement may still be subject to FDA inspection.

As of 2023, the FDA has 84,494 domestic FDA registered facilities with little less than 200,00 more in foreign registration, for a total of 282,726 FDA registered facilities. Domestically, California has the most FDA registered buildings with 12,070.

That's followed 5,638 and 5,167 registered facilities in Texas and Florida, respectively. Facilities undergo inspections to make sure they are up to code with the FDA's standards.

There are business in cosmetics, food, and more who have to register with the FDA. At Bakell® we are proud to uphold all required standards for partners, domestic & abroad, to shop with confidence.