FDA Inspection 929427 — Albany Medical Center Hospital
The FDA completed an inspection of Albany Medical Center Hospital on June 8, 2015 in Albany, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 8, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Albany, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12417 | 21 CFR 1271.260(e) | Periodic review of temperatures |
| 143 | 21 CFR 606.140(b) | Provisions to monitor lab test procedures & instruments |
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |