FDA Inspection 1272879 — Performance Orthopedics Associates Inc
The FDA completed an inspection of Performance Orthopedics Associates Inc on Jun 13, 2025 in Mountain Brk, AL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 13, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Mountain Brk, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12312 | 21 CFR 1271.160(b)(2) | Procedures for complaints and other information |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12443 | 21 CFR 1271.270(d) | Retention time (10 year rules) |