# FDA 483 - Performance Orthopedics Associates Inc - June 13, 2025

Source: https://www.keypedia.com/records/483/performance-orthopedics-associates-inc/2799c52f-afe6-4421-9f53-d7dc175c4c3e

> FDA 483 for Performance Orthopedics Associates Inc on June 13, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Performance Orthopedics Associates Inc
- Inspection Date: 2025-06-13
- Product Type: biologics
- Office Name: New Orleans District Office
- Summary: 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.

## Related Documents

- [483 - 2022-02-22](https://www.keypedia.com/records/483/performance-orthopedics-associates-inc/9e2ff2a7-3cee-4420-8ecf-8f2207463d5b)

## Related Officers

- [Juanelma H. Palmer](https://www.keypedia.com/people/juanelma-h-palmer/db3e79b5-d2d4-46d8-a075-4674dbc8c3d0)

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