FDA Inspection 853530 — New York Blood Center Enterprises
The FDA completed an inspection of New York Blood Center Enterprises on Oct 29, 2013 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). 7 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 29, 2013
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Westbury, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 155 | 21 CFR 606.160(b) | Required records |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9086 | 21 CFR 600.14(a)(1) | Who must report - manufacturer |