FDA WARNING_LETTER - East Bay Wholesales Corporation - September 03, 2025

The Food and Drug Administration (FDA) issued a Warning Letter to East Bay Wholesale Corporation following an inspection on September 2nd and 3rd, 2025, with previous inspections dating back to 2021. The inspection aimed to assess the company"s compliance with the Foreign Supplier Verification Program (FSVP) requirements under section 805 of the Federal Food, Drug, and Cosmetic Act and its implementing regulations (21 CFR part 1, subpart L).

The FDA found significant violations, specifically that East Bay Wholesale Corporation failed to develop, maintain, and follow an FSVP for the foods it imports into the United States. This non-compliance affects various products, including bananas, rice vermicelli, and sweet corn from identified foreign suppliers. An FSVP is crucial for importers to verify that their imported food meets U.S. food safety standards.

As a result, East Bay Wholesale Corporation is required to respond in writing within fifteen working days of receiving the letter. The response must detail specific corrective actions taken, supported by documentation such as a copy of the new FSVP and records demonstrating its implementation. Failure to adequately address these violations may lead to further regulatory actions, including the refusal of admission for imported food, placement on detention without physical examination, and prohibition of importation under U.S. law.