FDA Inspection 767179 — Upstate New York Transplant Services Inc
The FDA completed an inspection of Upstate New York Transplant Services Inc on February 17, 2012 in Williamsville, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 17, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- 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 |