FDA WARNING_LETTER - Agroson's LLC - September 03, 2021

On March 11, 2022, the FDA issued a Warning Letter to Agroson’s LLC following a Foreign Supplier Verification Program (FSVP) inspection from August 20 to September 3, 2021, with previous inspections on August 12, 2019, and January 29-February 16, 2021. The inspection found the company non-compliant with 21 CFR part 1, subpart L, for imported papayas and limes from multiple foreign suppliers.

Key violations include: 1. Failure to develop, maintain, and follow an FSVP (21 CFR 1.502(a)). 2. Failure to document review and assessment of foreign supplier hazard analyses, including verification that the analysis was conducted by a qualified individual (21 CFR 1.504(d)). 3. Failure to document foreign supplier approval based on performance and risk, including review of food safety records and verification of compliance with regulations (21 CFR 1.505(a)). 4. Failure to establish written procedures for foreign supplier verification activities, document determination of appropriate activities/frequency, and properly review/assess third-party audits (21 CFR 1.506). 5. Failure to provide English translations of requested FSVP records, including hazard analyses, foreign supplier evaluations, and verification documentation (2