FDA WARNING_LETTER - Jaramillo Spices Corp. - April 09, 2021

The FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Jaramillo Spices Corp in McAllen, TX, from March 26 to April 9, 2021, following a prior inspection on November 14, 2018. The inspections aimed to assess compliance with section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) and the implementing FSVP regulation (21 CFR part 1 subpart L). The FDA found that Jaramillo Spices Corp is not in compliance with these requirements for any food products it imports, including fresh tamarind, dried black beans, and vanilla flavoring. Specifically, the firm failed to develop, maintain, and follow an FSVP as mandated by section 805 of the FD&C Act and 21 CFR 1.502(a). The company received a Form FDA 483a after both inspections but has not submitted a response. Failure to adequately address these significant violations may lead to severe consequences, including refusal of admission for imported food products under section 801(a)(3) of the FD&C Act, detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under section 301(zz) of the FD&C Act. Jaramillo Spices Corp must respond in writing within fifteen working days, detailing corrective actions and providing supporting documentation, such as a copy of their FSVP and records demonstrating its implementation.