FDA WARNING_LETTER - Diamond Rock Food Imports Inc. - March 09, 2020

On March 9, 2020, the FDA conducted a Foreign Supplier Verification Program (FSVP) follow-up inspection at Diamond Rock Food Imports, Inc., following an initial inspection on September 22, 2017. The inspections 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 ensure imported food meets U.S. safety standards.

The firm was found non-compliant with FSVP requirements for Tomato Sauce and Refried Red Beans imported from one foreign supplier, and Grape Soft Drink from another. Diamond Rock Food Imports, Inc. did not have an FSVP for these or any other imported products, violating 21 CFR 1.502(a) and section 805 of the FD&C Act.

Form FDA 483a, FSVP Observations, was issued after both inspections. The firm's April 2, 2020 email indicated an intent to respond, but no response has been received to either Form 483a.

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, and potential detention without physical examination (DWPE) under Import Alert # 99-41. Importing food without a compliant FSVP is also