FDA WARNING_LETTER - Grupo Rm Usa, Inc. - May 06, 2020

On April 21, April 30, and May 6, 2020, the FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Grupo RM USA, Inc., located at 7991 NW 82nd Ave. Miami, FL 33166, following an initial on-site inspection on May 8, 2018. The inspections aimed to assess compliance with Section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR Part 1 Subpart L, which mandate risk-based activities for importers to verify imported food meets U.S. safety standards.

The FDA found Grupo RM USA, Inc. non-compliant, specifically noting the absence of FSVPs for imported food products, including Tropical Banana Soft Drink, Toasted Crackers, and Milk Candy. This violates 21 CFR 1.502(a), which requires developing, maintaining, and following an FSVP. The company failed to respond to Form FDA 483a, FSVP Observations, issued after both the 2018 and 2020 inspections.

Failure to correct these violations may lead to refusal of admission for imported food products under Section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) under Import Alert #99-4