Osteolife Biomedical I LLCFebruary 14, 2023

FDA 483 - Osteolife Biomedical I LLC - February 14, 2023

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Osteolife Biomedical I LLC, a human tissue processor in Miami, FL, was inspected by the FDA from February 6-14, 2023. The inspection revealed a significant issue with process validation, specifically concerning the bioburden determination for recently revalidated aseptic bone products. This indicates a failure to ensure that critical manufacturing processes are adequately controlled and verified.

Company: Osteolife Biomedical I LLC
Inspection Date: February 14, 2023
Product Type: Other
Office: Office of Medical Device and Radiological Health Division II
Person: Ivan E. Reyes

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ID · 7826a380-a81e-424c-bc75-8f659fa18bf9