# FDA 483 - Foundation Medical LLC - December 06, 2024

Source: https://www.keypedia.com/records/483/foundation-medical-llc/2b6fb563-f8f5-485f-887e-947b0c863372

> FDA 483 for Foundation Medical LLC on December 06, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Foundation Medical LLC
- Inspection Date: 2024-12-06
- Product Type: biologics
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/kellie-l-thommes/255a1b92-cd56-41f5-9622-82e8a629e153)

Company: https://www.keypedia.com/companies/foundation-medical-llc/be2ecb04-da5e-42c2-aa64-c018e995d43b

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d