FDA Inspection 752498 — New York Blood Center Enterprises
The FDA completed an inspection of New York Blood Center Enterprises on Nov 1, 2011 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). 8 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 1, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Westbury, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 159 | 21 CFR 606.160(a)(1) | Legibility and indelibility |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 57 | 21 CFR 606.60(a) | Maintain and clean equipment |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 78 | 21 CFR 606.100(c) | Record review prior to release |
| 9086 | 21 CFR 600.14(a)(1) | Who must report - manufacturer |
| 98 | 21 CFR 606.100(c) | Thorough investigations |