FDA Inspection 1018134 — Veterans Affairs Western Colorado Healthcare System
The FDA completed an inspection of Veterans Affairs Western Colorado Healthcare System on May 3, 2017 in Grand Junction, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 3, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Grand Junction, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 159 | 21 CFR 606.160(a)(1) | Legibility and indelibility |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 89 | 21 CFR 606.100(b)(10) | Controlling storage temperatures |