FDA Inspection 977456 — UNIVERSITY OF CALIFORNIA, LOS ANGELES
The FDA completed an inspection of UNIVERSITY OF CALIFORNIA, LOS ANGELES on June 2, 2016 in Los Angeles, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 2, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Los Angeles, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17763 | 21 CFR 212.20(d) | Determination need for investigation |
| 17764 | 21 CFR 212.20(e) | Written QA procedures established, followed |
| 17787 | 21 CFR 212.40(d) | Contamination, mix-ups and deterioration |
| 17822 | 21 CFR 212.50(b)(7) | Complete instructions, procedures, specs |
| 17839 | 21 CFR 212.50(c)(11) | Results of investigations |
| 17863 | 21 CFR 212.60(g)(3) | Complete record of all laboratory test data |