FDA WARNING_LETTER - Maos Produce - March 08, 2023

On March 8, 2023, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Maos Produce, following a previous inspection from April 26 to May 3, 2021. The inspection aimed to determine compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L.

The FDA found Maos Produce not in compliance with FSVP requirements for any imported foods, including fresh produce classified as "covered produce." Specifically, the company failed to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a). As an importer of covered produce, Maos Produce must have an FSVP demonstrating that its suppliers meet U.S. food safety standards, including those under 21 CFR part 112 (Standards for Produce Safety).

The company received a Form FDA 483a, FSVP Observations. A written response dated March 9, 2023, stating intent to work with a consultant and commitment to FSVP requirements, was deemed inadequate due to lack of details, timeframes, or supporting documentation.

Failure to address these violations may result in refusal of admission for imported food under section 801(a)(3) of the FD&C Act, placement on Detention Without Physical Examination (DWPE) via Import Alert #99-41, and