FDA WARNING_LETTER - FELLA GROUP LLC - December 10, 2021

On February 25, 2022, the FDA issued a Warning Letter to FELLA GROUP LLC following a Foreign Supplier Verification Programs (FSVP) inspection on December 10, 2021, and a previous inspection on July 28, 2020. 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 verify that imported food meets U.S. food safety standards.

The FDA found significant violations, specifically that FELLA GROUP LLC did not develop, maintain, and follow an FSVP for imported foods, as required by 21 CFR 1.502(a). This non-compliance was noted despite a previous commitment in response to the July 2020 inspection to develop an FSVP plan by July 31, 2021. A subsequent response dated January 6, 2022, again stated a plan to develop an FSVP by December 15, 2022, but adequate corrective actions or sufficient FSVP documentation have not been provided.

Failure to address these violations may result in further FDA action, including refusal of admission for imported food under section 801(a)(3) of the FD&C Act, and placement on detention without physical examination (DWPE) via Import Alert #