FDA WARNING_LETTER - Country Favor Inc. - February 13, 2025

On March 14, 2025, the FDA issued a Warning Letter to Country Favor Inc. following a Foreign Supplier Verification Program (FSVP) inspection on February 13, 2025, at their Maspeth, NY facility. This was a follow-up to an initial FSVP inspection conducted from June 1 to July 5, 2023. 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 imported food meets U.S. food safety standards.

The FDA found Country Favor Inc. not in compliance with 21 CFR part 1, subpart L, for foods from foreign suppliers listed in an attached document. A significant violation identified was the failure to develop, maintain, and follow an FSVP as required by 21 CFR part 1.502(a) for any imported foods, including specific examples not detailed in the provided text.

The firm failed to respond to the Form FDA 483a FSVP Observations issued on February 13, 2025, and also did not respond to the FDA 483a issued on July 5, 2023.

Failure to adequately address these violations may result in further FDA action, including refusal of admission for imported food under section 8