FDA 483 - FMT Services, LLC - May 02, 2024

FMI Services, LLC in Grand Prairie, TX, was inspected regarding its Foreign Supplier Verification Program (FSVP). The inspection revealed significant deficiencies across all eight observations, primarily concerning the lack of a developed FSVP, written procedures, hazard analyses, and proper documentation for foreign supplier verification activities and approvals. This includes a repeat observation from a previous inspection, indicating a persistent failure to comply with regulations.