FDA WARNING_LETTER - SALAZAR & SONS CORP - August 26, 2022

On December 29, 2022, the FDA issued a Warning Letter to Salazar & Sons Corp following Foreign Supplier Verification Program (FSVP) inspections conducted from July 12 to August 26, 2022, and previously on June 17, 2021. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1, Subpart L, which mandates importers to perform risk-based activities to verify imported food meets U.S. food safety standards.

The company was found to be non-compliant with FSVP requirements, specifically failing to develop, maintain, and follow an FSVP for any imported foods, including "covered produce" as defined in 21 CFR 112.3. This violates 21 CFR 1.502(a) and Section 805 of the FD&C Act. The FDA noted that no response was received to the Form FDA 483a FSVP Observations issued on August 26, 2022.

Failure to address these violations may lead to further FDA action, including refusal of admission for imported food under Section 801(a)(3) of the FD&C Act, and potential detention without physical examination (DWPE) under Import Alert #99-41. Importing food without a compliant FSVP is also prohibited under Section