Gilead Sciences, Inc.
Form 483 issued February 18, 2026 · La Verne, California
- Inspection
- Feb 9 – Feb 18, 2026
- Investigator
- Katherine C. Jacobi
- Observations
- 7
- Pages
- 10
- FEI number
- 3013189568
In short: On February 18, 2026, FDA issued a Form 483 with 7 observations to Gilead Sciences, Inc. in La Verne, California (FEI 3013189568) after an inspection that ran Feb 9 – Feb 18, 2026. The investigator was Katherine C. Jacobi. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
5 of 7 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.170(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Reserve drug product samples are not representative of each lot or batch of drug product and…
- 04
Test procedures relative to appropriate laboratory testing for…
This inspection in context
Katherine C. Jacobi
2 documents · 2026
Cites 211.160(a) (general requirements) more than any other section. Most of their documents are for sites in California.
The firmGilead Sciences, Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.170(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Gilead Sciences, Inc.?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Gilead Sciences, Inc.?
Katherine C. Jacobi is named on this Form 483, for the inspection of Feb 9 – Feb 18, 2026. Each investigator has a profile showing what they cite most.
When was Gilead Sciences, Inc. inspected by FDA?
The inspection ran Feb 9 – Feb 18, 2026, and the Form 483 is dated February 18, 2026.
How do I get the full Form 483 for Gilead Sciences, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.