FDA Inspection 845585 — Upstate New York Transplant Services Inc
The FDA completed an inspection of Upstate New York Transplant Services Inc on Aug 13, 2013 in Williamsville, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 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 |