FDA Inspection 897972 — Stony Brook University Hospital
The FDA completed an inspection of Stony Brook University Hospital on Sep 30, 2014 in Stony Brook, 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). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 30, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Stony Brook, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 246 | 21 CFR 640.25(a) | Storage temps./agitation |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 57 | 21 CFR 606.60(a) | Maintain and clean equipment |
| 61 | 21 CFR 606.60(a) | Provide proper equipment to meet requirements |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |