# FDA 483 - Performance Orthopedics Associates Inc - February 22, 2022

Source: https://www.keypedia.com/records/483/performance-orthopedics-associates-inc/9e2ff2a7-3cee-4420-8ecf-8f2207463d5b

> FDA 483 for Performance Orthopedics Associates Inc on February 22, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Performance Orthopedics Associates Inc
- Inspection Date: 2022-02-22
- Product Type: biologics
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Performance Orthopedics Associates Inc, a tissue distributor in Birmingham, AL, revealed significant deficiencies in their quality system. The firm failed to establish, maintain, and document appropriate procedures for core Current Good Tissue Practice (CGTP) requirements, including HCT/P receipt and distribution, facility cleaning, and SOP review. Additionally, the quality program lacked procedures for complaint handling and investigation of HCT/P deviations or adverse reactions.

## Related Documents

- [483 - 2025-06-13](https://www.keypedia.com/records/483/performance-orthopedics-associates-inc/2799c52f-afe6-4421-9f53-d7dc175c4c3e)

## Related Officers

- [Johnathan M Crayton](https://www.keypedia.com/people/johnathan-m-crayton/84dace1c-dfbe-4dcc-a9f2-f12bdd3e0c3a)

Company: https://www.keypedia.com/companies/performance-orthopedics-associates-inc/3a70797e-238b-41c4-968a-7eee40ebc2d7

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea