FDA Inspection 880678 — Gilead Sciences Inc
The FDA completed an inspection of Gilead Sciences Inc on May 16, 2014 in San Dimas, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 16, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San Dimas, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 1630 | 21 CFR 211.130(b) | Unlabeled filled containers controls |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 4323 | 21 CFR 211.115(a) | Reprocessing procedures lack steps to be taken |
| 4399 | 21 CFR 211.186(b)(7) | Theoretical yield statement including percentages |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |