FDA Inspection 734068 — Upstate New York Transplant Services, Inc.
The FDA completed an inspection of Upstate New York Transplant Services, Inc. on July 12, 2011 in Tonawanda, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 12, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Tonawanda, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |