Foundation Medical LLCDecember 6, 2024

FDA 483 - Foundation Medical LLC - December 06, 2024

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Record Details

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.

Company: Foundation Medical LLC
Inspection Date: December 6, 2024
Product Type: Biologics
Office: Minneapolis District Office
Person: Kellie L. Thommes (Consumer Safety Officer)

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ID · 2b6fb563-f8f5-485f-887e-947b0c863372