OsteoLife Biomedical, LLCJanuary 27, 2022

FDA 483 - OsteoLife Biomedical, LLC - January 27, 2022

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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.

Company: OsteoLife Biomedical, LLC
Inspection Date: January 27, 2022
Product Type: Biologics
Office: Office of Medical Device and Radiological Health Division II
Person: Thai D. Truong (Investigator)

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ID · 62a6bbe8-936d-49dd-bded-e5339d3e78d4