FDA Inspection 1235551 — Supreme Orthopedic Systems - NOVA
The FDA completed an inspection of Supreme Orthopedic Systems - NOVA on Apr 10, 2024 in Falls Church, VA. 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 10, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Falls Church, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12329 | 21 CFR 1271.160(d) | Documentation/approval prior to implementation |
| 12370 | 21 CFR 1271.200(c) | Calibration procedures and schedules (general) |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12417 | 21 CFR 1271.260(e) | Periodic review of temperatures |
| 12452 | 21 CFR 1271.290(d) | Recording I.D. code and type of HCT/P |