FDA Inspection 675139 — The Mount Sinai Hospital
The FDA completed an inspection of The Mount Sinai Hospital on August 17, 2010 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
- August 17, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 227 | 21 CFR 640.4(h) | Storage temperatures after collection |
| 81 | 21 CFR 606.100(b)(2) | Donor qualifying tests & measurements |
| 9220 | 21 CFR 606.100(b)(21) | Donor notification |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 98 | 21 CFR 606.100(c) | Thorough investigations |