FDA Inspection 772732 — New York Blood Center Enterprises
The FDA completed an inspection of New York Blood Center Enterprises on Mar 12, 2012 in Melville, 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
- Mar 12, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Melville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |