483
Osteolife Biomedical I LLCOsteolife Biomedical I LLC – FDA 483, Feb 14, 2023
Record Details
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.
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ID · 7826a380-a81e-424c-bc75-8f659fa18bf9
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