FDA WARNING_LETTER - Dry Produce Division USA LLC - March 26, 2021

The FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Dry Produce Division USA LLC from March 24-26, 2021, following a previous inspection on July 24, 2018. The inspections aimed to assess compliance with 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 any of the foods it imports, including dried Guajillo chili peppers, pumpkin seeds (roasted and salted), and dried chickpea beans, as required by 21 CFR 1.502(a). The firm did not respond to the Form FDA 483a observations issued after both the 2018 and 2021 inspections. Dry Produce Division USA LLC is required to respond in writing within fifteen working days, detailing specific corrective actions, providing supporting documentation such as a copy of their FSVP and implementation records, and explaining any delays. Failure to adequately address these violations may lead to further regulatory action, including 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.