Lux Commercial Group LLC – FDA Warning Letter, Mar 3, 2021

On May 18, 2021, the FDA issued a Warning Letter to Mr. Rodriguez (CMS # 614025) following a remote Foreign Supplier Verification Program (FSVP) inspection conducted from March 2-3, 2021, and an initial inspection on March 4, 2019. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR part 1 subpart L.

The FDA found significant violations, specifically that the importer failed to develop, maintain, and follow an FSVP for any imported food products, including Mango Drink, Corn Chips, and Corn Flour from various foreign suppliers. This violates 21 CFR 1.502(a). The importer did not respond to Form FDA 483a, FSVP Observations, issued after both the 2019 and 2021 inspections.

Failure to address these violations may result in refusal of admission of imported food products under Section 801(a)(3) of the FD&C Act, and potential detention without physical examination (DWPE) under Import Alert # 99-41. Importing food without a compliant FSVP is prohibited under Section 301(zz) of the FD&C Act.

The importer must respond in writing within fifteen working days, detailing corrective actions, including documentation like revised FSVPs