FDA Inspection 967569 — Gallup Indian Medical Center Blood Bank
The FDA completed an inspection of Gallup Indian Medical Center Blood Bank on Nov 18, 2015 in Gallup, NM. 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 18, 2015
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Gallup, NM (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2406 | 21 CFR 211.194(a)(8) | Identification of Person Performing Review of Lab Records |
| 92 | 21 CFR 606.100(b)(13) | Procedures to relate blood from donor to final disposition |
| 9424 | 21 CFR 680.1(b)(2)(iii) | Maintained |
| 98 | 21 CFR 606.100(c) | Thorough investigations |