Gilead Sciences, Inc. — FDA Facility Profile
Gilead Sciences, Inc. is an FDA-registered facility (FEI 3013189568) located in La Verne, CA, US. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 3 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Feb 18, 2026: Voluntary Action Indicated (VAI)
- Inspections on record
- 3 (2 VAI, 1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Form 483 and inspection documents
- 1 in FDA's reading room
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Feb 18, 2026 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Procedures for sterile drug products (21 CFR 211.113(b)) Following/documenting laboratory controls (21 CFR 211.160(a)) Sterility/pyrogens - test methods written, followed (21 CFR 211.167(a)) and 3 more |
| Dec 17, 2021 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Training , Education , Experience overall (21 CFR 211.25(a)) Validation lacking for sterile drug products (21 CFR 211.113(b)) Buildings not maintained in good state of repair (21 CFR 211.58) |
| May 14, 2019 | No Action Indicated (NAI) | No citations listed |
Form 483s and inspection documents
- Feb 18, 2026: 483 on FDA.gov
Facility details
- Company
- Gilead Sciences, Inc.
- Location
- La Verne, CA (US)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; LABEL; MANUFACTURE; PACK
- Source
- decrs