FDA WARNING_LETTER - DELIIMPORTS, LLC - September 28, 2022

On December 12, 2022, the FDA issued a Warning Letter to DELIIMPORTS, LLC, following a Foreign Supplier Verification Program (FSVP) inspection from September 12-28, 2022, and a previous inspection on February 28, 2020. The inspection revealed the company is not in compliance with Section 805 of the FD&C Act and 21 CFR Part 1, Subpart L, which requires importers to perform risk-based activities to verify imported food meets U.S. food safety standards.

The primary violation cited is the failure to develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR 1.502(a). The FDA investigator issued a Form FDA 483a FSVP Observations on September 28, 2022, to which no response has been received.

The FDA noted that DELIIMPORTS, LLC might meet the definition of a "very small importer" under 21 CFR 1.500. If so, the company must document this status and comply with modified requirements, including obtaining written assurance from foreign suppliers that food is produced in compliance with applicable U.S. food safety regulations.

Failure to address these violations may result in further action, including refusal of admission of imported food under Section 801(a)(3)