Cecilia Alvarez – FDA Warning Letter, Jul 28, 2022

On November 22, 2022, the FDA issued a Warning Letter to Cecilia Alvarez following a Foreign Supplier Verification Program (FSVP) inspection conducted from July 26-28, 2022, at 409 E. Geranium Ave., McAllen, TX. This was the second FSVP inspection, with the first occurring from April 21-23, 2020. The inspection found significant violations of section 805 of the FD&C Act and 21 CFR part 1, subpart L, as the firm failed to develop, maintain, and follow an FSVP for any imported foods. An FDA Form 483a, FSVP Observations, was issued on July 28, 2022, to which no response was received.

The FDA noted that the firm might qualify as a "very small importer" under 21 CFR 1.500, which would allow compliance with modified requirements in 21 CFR 1.512. However, even as a very small importer, annual documentation of this status and obtaining written assurances from foreign suppliers every two years regarding compliance with U.S. food safety standards (sections 402, 403(w), 418, or 419 of the FD&C Act) are required.

Failure to address these violations may result in refusal of