FDA Inspection 1063883 — The University Of Utah
The FDA completed an inspection of The University Of Utah on Aug 30, 2018 in Salt Lake City, UT. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 30, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 17763 | 21 CFR 212.20(d) | Determination need for investigation |
| 17853 | 21 CFR 212.60(d) | Supplies adequately controlled |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |