FDA Inspection 812875 — New York Blood Center Enterprises
The FDA completed an inspection of New York Blood Center Enterprises on Jan 15, 2013 in Rye, 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 15, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Rye, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 208 | 21 CFR 640.3(a)(1) | Donor suitability procedures not followed |
| 38 | 21 CFR 606.40(b) | Adequate lighting, ventilation, and screening |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |