FDA Inspection 1159086 — Gilead Sciences, Inc.
The FDA completed an inspection of Gilead Sciences, Inc. on December 17, 2021 in La Verne, CA. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 17, 2021
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- La Verne, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |