FDA Inspection 544732 — The Mount Sinai Hospital
The FDA completed an inspection of The Mount Sinai Hospital on November 18, 2008 in New York, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 18, 2008
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3684 | 21 CFR 820.75(a) | Documentation - specific items |
| 75 | 21 CFR 606.100(a) | SOP compliance |
| 9236 | 21 CFR 630.40(b)(1) | Deferred or not eligible |