FDA WARNING_LETTER - Minland of Texas, Inc. - June 12, 2024

On July 23, 2024, the FDA issued a Warning Letter to Minland of Texas, Inc. following a remote Foreign Supplier Verification Program (FSVP) inspection on June 11-12, 2024, and previous inspections on March 29 - April 14, 2023, and October 5-6, 2023. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L, which mandate importers to perform risk-based activities to verify imported food meets U.S. food safety standards.

The FDA found significant violations, specifically that Minland of Texas, Inc. failed to develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR part 1.502(a). This non-compliance violates section 805 of the FD&C Act. An FDA Form 483a FSVP Observations was issued on June 12, 2024, to which no response has been received.

Failure to 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 placement on detention without physical examination (DWPE) via Import Alert #99-41. Importing food without