Guillermo Osuna

Warning LetterOpen

Guillermo Antonio Osuna President Guillermo Osuna 4843 Faintail Place San Diego , CA 92154-8906 United StatesFEI 3013168021Issued Jun 25, 2021Division of Southwest Imports

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3013168021.

Violations1

Issue DateJun 25, 2021

Product TypeOther

StatusOpen

Letter Details

Firm: Guillermo Osuna
Location: Guillermo Antonio Osuna President Guillermo Osuna 4843 Faintail Place San Diego , CA 92154-8906 United States
FEI Number: 3013168021
Country: United States
Issue Date: June 25, 2021
Issuing Office: Division of Southwest Imports
Product Type: Other
Status: Open

Summary

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.

Guillermo Osuna FDA Warning Letter, June 25, 2021