483
OsteoLife Biomedical, LLCOsteoLife Biomedical, LLC – FDA 483, Jan 27, 2022
Record Details
An FDA inspection of OsteoLife Biomedical, LLC in Jupiter, FL, an HCT/P storage and distribution facility, revealed significant deficiencies. The firm failed to establish and implement a tracking system for HCT/Ps from donor to consignee. Additionally, the company lacked appropriate procedures for core CGTP requirements, including environmental control, product recall, and product receipt, storage, and distribution.
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ID · 62a6bbe8-936d-49dd-bded-e5339d3e78d4
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