FDA Inspection 605242 — New York Blood Center Enterprises
The FDA completed an inspection of New York Blood Center Enterprises on Sep 4, 2009 in Westbury, 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
- Sep 4, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Westbury, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |