FDA Inspection 776705 — New York Firefighters Skin Bank New York Presbyterian Hosp
The FDA completed an inspection of New York Firefighters Skin Bank New York Presbyterian Hosp on Apr 23, 2012 in New York, 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 23, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12371 | 21 CFR 1271.200(a) | Cleaned, sanitized per established schedules |
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |