FDA WARNING_LETTER - Del Valle Import & Export 3, Inc. - February 28, 2023

The FDA conducted a Foreign Supplier Verification Program (FSVP) inspection at Del Valle Import & Export 3, Inc. dba El Progreso Imports from February 22-28, 2023, following previous inspections. The inspection revealed significant violations of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) and the FSVP regulation in 21 CFR part 1 subpart L. The primary violation identified was the firm's failure to develop, maintain, and follow an FSVP for foods from foreign suppliers, as required by 21 CFR 1.502(a). Specifically, the firm did not develop an FSVP for most imported foods. While a written response was provided with some FSVP records, it lacked comprehensive documentation for all products and did not indicate completion or timelines for proposed corrective actions. The FDA cannot evaluate the adequacy of these actions without further information. The firm must respond within fifteen working days, detailing specific corrective actions, providing supporting documentation, and explaining any delays. Failure to comply may result in refusal of admission for imported food products, detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under section 301(zz) of the FD&C Act.