FDA Inspection 1099630 — Arnot Ogden Medical Center
The FDA completed an inspection of Arnot Ogden Medical Center on August 14, 2019 in Elmira, 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
- August 14, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Elmira, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 18038 | 21 CFR 606.100(b) | SOPs for investigations, records |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |