FDA WARNING_LETTER - J&R Produce, Inc. - March 14, 2024

On May 28, 2024, the FDA issued a Warning Letter to J&R Produce, Inc. following a Foreign Supplier Verification Program (FSVP) inspection conducted on March 13-14, 2024, at their Houston, TX facility. This was the fourth inspection since August 2020. The inspection revealed significant violations of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the implementing FSVP regulation (21 CFR part 1, subpart L).

Specifically, J&R Produce, Inc. failed to develop, maintain, and follow an FSVP for any imported foods, including serrano peppers, husk tomatoes, and jalapeno peppers. The company provided an audit certificate for a packing house operation, but not for the actual foreign supplier, which is the establishment that manufactures/processes or grows the food. As an importer of "covered produce," J&R Produce, Inc. must ensure their supplier complies with produce safety standards (21 CFR part 112). The FDA noted that previous FSVP documents provided were for a packing house, not the foreign supplier, and no response to the Form FDA 483a issued on March 14, 2024, has been received.

Failure to address these violations may result in refusal of admission for imported food under section 801(a)(3) of