FDA Inspection 950864 — First Choice Prosthetic, Corp
The FDA completed an inspection of First Choice Prosthetic, Corp on November 13, 2015 in Ponce, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 13, 2015
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Ponce, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |