FDA Inspection 675432 — Upstate New York Transplant Services, Inc.
The FDA completed an inspection of Upstate New York Transplant Services, Inc. on Aug 9, 2010 in Tonawanda, 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 9, 2010
- Fiscal Year
- 2010
- 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 |
| 93 | 21 CFR 606.100(b)(14) | QC procedures for supplies and reagents |