FDA Inspection 791259 — Stony Brook University Hospital
The FDA completed an inspection of Stony Brook University Hospital on July 18, 2012 in Stony Brook, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 18, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Stony Brook, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 159 | 21 CFR 606.160(a)(1) | Legibility and indelibility |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |