FDA Inspection 1136000 — New York Blood Center Enterprises
The FDA completed an inspection of New York Blood Center Enterprises on Feb 24, 2021 in Massapequa, 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 24, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Massapequa, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |
| 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 |