FDA Inspection 845585 — Upstate New York Transplant Services Inc
The FDA completed an inspection of Upstate New York Transplant Services Inc on August 13, 2013 in Williamsville, NY. 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
- August 13, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Williamsville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12351 | 21 CFR 1271.190(d)(1) | Procedures for cleaning, sanitation |
| 12364 | 21 CFR 1271.195(c) | Monitoring-microorganisms where appropriate |
| 12436 | 21 CFR 1271.270(a) | Accurate, indelible, legible |