FDA Inspection 773721 — Surgical Solutions JA PR Inc.
The FDA completed an inspection of Surgical Solutions JA PR Inc. on March 15, 2012 in San Juan, PR. 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
- March 15, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- San Juan, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12415 | 21 CFR 1271.260(e) | Temperature limits |
| 12429 | 21 CFR 1271.265(d) | Shipping conditions appropriate |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |