FDA Inspection 1303442 — New York Blood Center Enterprises
The FDA completed an inspection of New York Blood Center Enterprises on Feb 19, 2026 in New Hyde Park, 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 19, 2026
- Fiscal Year
- 2026
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- New Hyde Park, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 61 | 21 CFR 606.60(a) | Provide proper equipment to meet requirements |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9078 | 21 CFR 600.12(a) | Maintenance - tracing |