FDA Inspection 811144 — Supreme Orthopedic Systems Inc
The FDA completed an inspection of Supreme Orthopedic Systems Inc on December 14, 2012 in Columbia, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 14, 2012
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Columbia, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12329 | 21 CFR 1271.160(d) | Documentation/approval prior to implementation |