FDA Inspection 1065316 — Gilead Sciences, Inc.
The FDA completed an inspection of Gilead Sciences, Inc. on July 17, 2018 in Foster City, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 17, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Foster City, CA (United States)
Additional Details
Risk Evaluation and Mitigation Strategies (REMS)
Citations
| ID | CFR | Description |
|---|---|---|
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |