FDA WARNING_LETTER - Dulces La Mejor, LLC - June 16, 2021

On September 15, 2021, the FDA issued a Warning Letter to Dulces La Mejor, LLC, following Foreign Supplier Verification Program (FSVP) inspections on June 2 and 16, 2021, and a previous inspection on July 25, 2018. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L.

The primary violation identified was the failure to develop, maintain, and follow an FSVP for any imported food products, as required by 21 CFR 1.502(a). This deficiency was noted for all imported food products.

While the company's responses on June 17, 2021, and August 3, 2021, indicated that Maurilio Campos would be the qualified individual, had completed FSVP training, and planned to develop FSVPs within 3-6 months, no evidence of actual FSVP development or implementation was provided.

Failure to adequately address these violations may result in further FDA action, including refusal of admission for imported food under section 801(a)(3) of the FD&C Act, detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under section 301(zz) of the FD&C Act.

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