FDA Inspection 767179 — Upstate New York Transplant Services Inc
The FDA completed an inspection of Upstate New York Transplant Services Inc on Feb 17, 2012 in Williamsville, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Feb 17, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Williamsville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |
| 12369 | 21 CFR 1271.200(b) | Procedures inadequate |
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |