FDA Inspection 1209368 — New York Blood Center Enterprises
The FDA completed an inspection of New York Blood Center Enterprises on Jul 6, 2023 in Rye, 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). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 6, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Rye, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9078 | 21 CFR 600.12(a) | Maintenance - tracing |
| 9089 | 21 CFR 600.14(c) | When to report |
| 98 | 21 CFR 606.100(c) | Thorough investigations |