FDA Inspection 774194 — New York Blood Center Enterprises
The FDA completed an inspection of New York Blood Center Enterprises on Mar 29, 2012 in Rockville Centre, 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
- Mar 29, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Rockville Centre, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 41 | 21 CFR 606.40(a)(1) | Provide space for examination |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |