Loading…
Guillermo Osuna, a food importer in San Diego, failed to establish Foreign Supplier Verification Programs (FSVPs) for bottled water products (cucumber-lemon, hibiscus-jamaica, and lychee varieties) imported from Envasadora La Suprema SA de CV, violating section 805 of the FD&C Act and 21 CFR part 1 subpart L. The company did not develop, maintain, or follow required FSVPs for any of the foods it imported, despite receiving FDA 483a observations documenting these violations during inspections conducted in February 2019 and February-March 2021, and failed to respond to either notice.