FDA WARNING_LETTER - LA ALDEA DISTRIBUTORS INC - November 01, 2022

The FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of La Aldea Distributors Inc. in San Antonio, Texas, from October 20 to November 1, 2022, following a previous inspection in 2021. The inspection aimed to assess compliance with section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 1, subpart L. The FDA found significant violations, indicating the company was not in compliance with FSVP requirements for the foods it imports. Specifically, La Aldea Distributors Inc. failed to develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a) for any of its imported foods. The company's email responses acknowledging the need for a third-party FSVP developer and requesting more time were deemed inadequate due to a lack of supporting documentation. The FDA warned that failure to adequately address these violations could lead to further actions, including refusal of admission for imported food under section 801(a)(3) of the FD&C Act, detention without physical examination (DWPE) under Import Alert #99-41, and prohibition under section 301(zz). La Aldea Distributors Inc. is required to respond in writing within fifteen working days, providing documentation of specific corrective actions, such as a copy of their developed FSVP and records demonstrating its implementation.