FDA WARNING_LETTER - V & L Produce, Inc. - September 09, 2025

The FDA issued a Warning Letter to V & L Produce, Inc. on October 9, 2025, following a Foreign Supplier Verification Program (FSVP) inspection conducted on September 2, 5, 8, & 9, 2025. The inspection revealed significant violations of section 805 of the Federal Food, Drug, and Cosmetic Act and the implementing FSVP regulation (21 CFR part 1, subpart L). The primary issue was the company"s failure to develop, maintain, and follow an FSVP for any of the foods it imports, including fresh produce like Jalapeno Pepper, Green Onions, and Husk Tomatoes. The FSVP regulation requires importers to verify that foreign suppliers meet U.S. food safety standards, including produce safety regulations. Although V & L Produce responded on September 22, 2025, stating intentions to develop an FSVP, the FDA deemed the response inadequate due to the lack of supporting documentation for corrective actions. The company must respond in writing within 15 working days, detailing specific corrections and providing comprehensive documentation, such as a copy of their implemented FSVP and relevant records. Failure to adequately address these violations could result in severe consequences, including refusal of admission for imported food and detention without physical examination, emphasizing the company"s responsibility to ensure full compliance.