FDA Inspection 1294098 — New York Blood Center Enterprises
The FDA completed an inspection of New York Blood Center Enterprises on Dec 5, 2025 in Melville, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Dec 5, 2025
- Fiscal Year
- 2026
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Melville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |