FDA WARNING_LETTER - A.D. BERRIES @ MORE LLC - May 28, 2025

The FDA issued a warning letter to A.D. BERRIES @ MORE LLC following inspections conducted from May 22 to May 28, 2025, and previously from November 28 to November 30, 2022, at their McAllen, Texas location. These inspections aimed to assess compliance with the Foreign Supplier Verification Program (FSVP) as mandated by section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the corresponding regulation in 21 CFR part 1, subpart L.

The primary violation identified was the company"s failure to develop, maintain, and implement an FSVP for the foods imported from foreign suppliers. This includes fresh produce potentially classified as "covered produce," which requires adherence to safety standards equivalent to those outlined in section 419 of the FD&C Act and 21 CFR part 112.

The FDA"s letter highlights the absence of necessary documentation and corrective actions from A.D. BERRIES @ MORE LLC, despite their acknowledgment of the issue in a response dated June 4, 2025. The company is required to submit a detailed corrective action plan within 15 working days, including documentation of compliance efforts and any additional relevant information.

Failure to address these violations may result in further regulatory actions, such as refusal of food admission or detention without physical examination. The company is urged to communicate with the FDA"s Compliance Officer, Ernesto Barba, for further guidance and to ensure compliance with the FSVP regulations.