FDA 483 - Foundation Medical LLC - December 06, 2024

An FDA inspection of Foundation Medical LLC, a human tissue distributor in Mendota Heights, MN, revealed significant deficiencies in their handling of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The firm failed to record and maintain storage temperatures for HCT/Ps and lacked adequate procedures for manufacturing, storing, and distributing these products. These issues indicate a failure to ensure product quality and safety.