FDA WARNING_LETTER - El Salvador Products Inc. - June 08, 2022

On June 3-8, 2022, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of El Salvador Products Inc. at 12130 Dairy Ashford Sugarland, TX. A previous inspection occurred on May 21-23, 2019. The recent inspection revealed the company is not in compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L, which requires importers to perform risk-based activities to verify imported food meets U.S. food safety standards.

The primary violation is the failure to develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR 1.502(a). The FDA issued a Form FDA 483a, FSVP Observations, on June 8, 2022, to which no response has been received.

Additionally, the facility is subject to the registration requirement in section 415 of the FD&C Act and 21 CFR Part 1, Subpart H, but does not have a valid food facility registration, which is a prohibited act under section 301(dd).

Failure to adequately address these violations may result in further action, including refusal of admission for imported food under section 801(a)(3) and placement on detention without physical examination (DWPE) via Import Alert