FDA WARNING_LETTER - J R Imports LLC - August 31, 2022

On November 9, 2022, the FDA issued a Warning Letter to J R Imports LLC following a Foreign Supplier Verification Program (FSVP) inspection conducted from August 5 to August 31, 2022, with a previous inspection from November 19 to December 1, 2020. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1 Subpart L.

The FDA found that J R Imports LLC was not in compliance with FSVP requirements for imported foods. Specifically, the firm failed to develop, maintain, and follow an FSVP for any imported foods, including "covered produce" as defined in 21 CFR 112.3. This means the company did not demonstrate that its suppliers produce food in compliance with U.S. food safety standards, particularly those under Section 419 of the FD&C Act and 21 CFR Part 112 (Standards for Produce Safety).

The company received a Form FDA 483a, FSVP Observations, on August 31, 2022, but no response was received. Failure to adequately address these violations may lead to further FDA action, including refusal of admission for imported foods under Section 801(a)(3) of the FD&C Act and potential detention without physical examination (DWPE) under Import Alert #9