Las Dos Californias Inc DBA Dulceria los Cuates

Warning LetterOpen

Mr. Juan Manuel Ramirez Owner Las Dos Californias Inc DBA Dulceria los Cuates 2155 Paseo De Las Americas Suite 33 San Diego , CA 92154-7907 United StatesFEI 3012424468Issued Apr 1, 2022Division 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 3012424468.

Violations4

Issue DateApr 1, 2022

Product TypeOther

StatusOpen

Letter Details

Firm: Las Dos Californias Inc DBA Dulceria los Cuates
Location: Mr. Juan Manuel Ramirez Owner Las Dos Californias Inc DBA Dulceria los Cuates 2155 Paseo De Las Americas Suite 33 San Diego , CA 92154-7907 United States
FEI Number: 3012424468
Country: United States
Issue Date: April 01, 2022
Issuing Office: Division of Southwest Imports
Product Type: Other
Status: Open

Summary

Las Dos Californias Inc DBA Dulceria los Cuates, a food and beverage importer based in San Diego, failed to comply with the Foreign Supplier Verification Program (FSVP) regulation required under section 805 of the Federal Food, Drug, and Cosmetic Act. During an October 2021 inspection—the third FDA inspection of the company since 2018—investigators identified significant violations of 21 CFR part 1, subpart L, which requires importers to perform risk-based verification activities to ensure imported foods meet applicable U.S. food safety standards. The company's response indicated it had not yet implemented adequate FSVPs for its imported products and was only beginning to develop the necessary documentation with external assistance.

Las Dos Californias Inc DBA Dulceria los Cuates FDA Warning Letter, April 1, 2022