FDA WARNING_LETTER - Rich River Produce, LLC - May 24, 2022

The FDA issued a Warning Letter to Rich River Produce, LLC following Foreign Supplier Verification Program (FSVP) inspections on May 24, 2022, and November 19, 2020. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L. The primary violation identified was the firm's failure to develop, maintain, and follow an FSVP for any imported foods, including covered produce, as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Although third-party audit certificates were provided, they were deemed incomplete and not properly applied to an FSVP. Additionally, the firm failed to provide required importer information, including its name, email address, and DUNS number, electronically when filing entries for specific shipments of fresh serrano, bell, and jalapeno peppers, violating 21 CFR 1.509(a). The FDA emphasized that the use of 'UNK' for entity identification would no longer be an option for entries starting July 24, 2022. The firm must respond within fifteen working days, detailing corrective actions, providing documentation, and explaining any delays. Failure to comply could result in refusal of admission for imported food under section 801(a)(3) of the FD&C Act and detention without physical examination (DWPE).