All Good Foods, Inc. – FDA Warning Letter, Dec 2, 2021

On February 7, 2022, the FDA issued a Warning Letter to All Good Foods, Inc. following Foreign Supplier Verification Program (FSVP) inspections on December 1-2, 2021, and April 26-30, 2021. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L, which mandate risk-based activities for importers to ensure imported food meets U.S. safety standards.

The FDA found All Good Foods, Inc. not in compliance with these requirements, specifically citing a failure to develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR 1.502(a). This significant violation means the company is not in compliance with section 805 of the FD&C Act. An FDA Form 483a, FSVP Observations, was issued on December 2, 2021, but no response has been received.

Failure to adequately address these violations may lead to further FDA action, including refusal of admission for imported food products under section 801(a)(3) of the FD&C Act, and potential detention without physical examination (DWPE) under Import Alert # 99-41. Importing food without a compliant FSVP is also prohibited under section 301(zz