FDA Inspection 1247814 — Supreme Orthopedic Systems Inc
The FDA completed an inspection of Supreme Orthopedic Systems Inc on August 23, 2024 in Columbia, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 23, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Columbia, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12368 | 21 CFR 1271.200(a) | Capable of valid results |
| 12370 | 21 CFR 1271.200(c) | Calibration procedures and schedules (general) |
| 12417 | 21 CFR 1271.260(e) | Periodic review of temperatures |