FDA 483 - Performance Orthopedics Associates Inc - June 13, 2025
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Performance Orthopedics Associates Inc, a human tissue distributor in Mountain Brk, AL, was cited for significant deficiencies during an FDA inspection. Observations included a widespread lack of established procedures for core Current Good Tissue Practice (CGTP) requirements, including HCT/P manufacturing, receipt, distribution, facility sanitation, and quality program elements like complaint handling and deviation investigations. Additionally, the firm failed to retain HCT/P records for the required 10-year period.
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ID · 2799c52f-afe6-4421-9f53-d7dc175c4c3e