FDA Inspection 945089 — New York Blood Center Enterprises
The FDA completed an inspection of New York Blood Center Enterprises on Sep 30, 2015 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). 7 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 30, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Rye, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 142 | 21 CFR 606.140(a) | Establishment of spec., standards, and test procedures |
| 143 | 21 CFR 606.140(b) | Provisions to monitor lab test procedures & instruments |
| 35 | 21 CFR 606.40 | Clean & orderly |
| 4368 | 21 CFR 211.188(b)(12) | Investigations made into any unexplained discrepancy |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 77 | 21 CFR 606.100(b) | Written SOPs available for use by personnel |
| 9089 | 21 CFR 600.14(c) | When to report |