FDA WARNING_LETTER - La Ilusion Fresh Guava Inc. - March 04, 2022

The FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of La Ilusion Fresh Guava Inc. on March 4, 2022, following a previous inspection in April 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, which mandates importers perform risk-based activities to ensure imported food meets U.S. safety standards. The firm was found to be non-compliant, specifically failing to develop, maintain, and follow an FSVP for any imported foods, including fresh guava and pitaya/dragon fruit, as required by 21 CFR 1.502(a). This constitutes a significant violation of the FSVP regulation. The FDA issued a Form FDA 483a, to which no response has been received. The letter emphasizes that the firm must respond in writing within fifteen working days, detailing corrective actions, providing supporting documentation, and explaining any delays. Failure to address these violations could result in severe business implications, including refusal of admission for imported food, detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under section 301(zz) of the FD&C Act. The FDA also noted the possibility of the firm being a "very small importer" and outlined associated modified FSVP requirements, including obtaining written assurances from foreign suppliers and providing a Unique Facility Identifier (UFI) like a DUNS number during import filings.