Export Guatemala Corporation Warning Letter Details

Summary

Export Guatemala Corporation, a food and beverage importer, failed to comply with Foreign Supplier Verification Program (FSVP) requirements under 21 CFR Part 1 Subpart L during FDA inspections conducted in November 2020 and February 2022. The company did not perform required risk-based verification activities to ensure imported foods met applicable U.S. food safety standards and lacked adequate documentation from its suppliers in Guatemala. In response to FDA's observations, the company acknowledged insufficient supplier responses and requested six months to obtain necessary FSVP records, but did not provide supporting documentation or a detailed compliance plan.