FDA WARNING_LETTER - Productos Bredy USA LLC - March 16, 2021

On March 11-16, 2021, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Productos Bredy USA LLC, following an initial inspection on September 24, 2018. The inspection aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR part 1 subpart L, which mandate risk-based activities for importers to verify food safety standards.

The inspection revealed significant violations: Productos Bredy USA LLC failed to develop, maintain, and follow an FSVP for any imported food products, including (b)(4) Soft Drinks from supplier (b)(4). This violates 21 CFR 1.502(a) and Section 805 of the FD&C Act. Despite a 2018 commitment to develop FSVPs and receiving a Form FDA 483a on March 16, 2021, no response or corrective action was observed.

Failure to address these violations may lead to refusal of admission for imported products under Section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under Section 301(zz) of the FD&C Act. The company must respond in writing within fifteen working days, detailing corrective actions, providing documentation (