FDA Inspection 1145185 — Upstate New York Transplant Services Inc
The FDA completed an inspection of Upstate New York Transplant Services Inc on July 1, 2021 in Williamsville, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- July 1, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Williamsville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12287 | 21 CFR 1271.80(c) | Kits not FDA approved, specifically labeled |
| 12319 | 21 CFR 1271.160(b)(3) | Actions taken and documented |