FDA Inspection 1050701 — New York Blood Center Enterprises
The FDA completed an inspection of New York Blood Center Enterprises on May 1, 2018 in Massapequa, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 1, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Massapequa, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 246 | 21 CFR 640.25(a) | Storage temps./agitation |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |