El Dorado Imports Inc – FDA Warning Letter, Dec 17, 2021

On December 9-17, 2021, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of El Dorado Imports Inc. in Spring, Texas, following a previous inspection on June 4, 2019. The inspection found the company non-compliant with section 805 of the FD&C Act and 21 CFR part 1, subpart L, for imported foods.

The primary violation is the failure to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a) for any imported food products, including coconut candy, sugar baked flour tortillas, and sweet bread with pineapple. The company acknowledged this deficiency in a January 5, 2022, response, promising compliance by April 2022, but provided no evidence of steps taken. A similar promise was made after the 2019 inspection.

The FDA noted the firm might qualify as a "very small importer" under 21 CFR 1.500. If so, modified requirements under 21 CFR 1.512 apply, including annual documentation of eligibility and obtaining written assurance from foreign suppliers every two years regarding compliance with U.S. food safety standards.

Failure to address these violations may result in refusal of admission for imported food under section 801(a)(3) of the FD&C Act, detention