FDA Inspection 1226373 — New York Blood Center Enterprises
The FDA completed an inspection of New York Blood Center Enterprises on Dec 22, 2023 in Ronkonkoma, 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
- Dec 22, 2023
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Ronkonkoma, 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 |