FDA Inspection 860731 — New York Blood Center Enterprises
The FDA completed an inspection of New York Blood Center Enterprises on Dec 23, 2013 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 23, 2013
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Melville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 159 | 21 CFR 606.160(a)(1) | Legibility and indelibility |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 84 | 21 CFR 606.100(b)(5) | Accurate measurement of quantity of blood |
| 9225 | 21 CFR 606.171 | Biological product deviation report |