Overview
- 21 FDA inspections are on record.
- 13 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-01-16.
At a glance
Inspections
21
Form 483s
13
EIRs
7
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Jan 2026 – 16 Jan 2026 | Human Drugs | Clean | |
| 22 Jan 2025 – 29 Jan 2025 | Human Drugs | Clean | |
| 16 Jan 2024 – 22 Jan 2024 | Human Drugs | 483 | View 483 → |
| 6 Aug 2020 – 18 Aug 2020 | Human Drugs | Clean | |
| 7 Jul 2020 – 22 Jul 2020 | Human Drugs | 483 | View 483 → |
| 28 Mar 2019 – 4 Apr 2019 | Human Drugs | Clean | |
| 9 Jul 2018 – 17 Jul 2018 | Human Drugs | 483 | View 483 → |
| 2 May 2016 – 11 May 2016 | Human Drugs | 483 | On file |
| 7 Apr 2016 – 14 Apr 2016 | Human Drugs | Clean | |
| 15 Jul 2014 – 25 Jul 2014 | Human Drugs | 483 | View 483 → |
| 8 Jan 2014 – 15 Jan 2014 | Human Drugs | 483 | View 483 → |
| 23 Sep 2013 – 9 Oct 2013 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Jan 2024
21 CFR 314.80(c)(1)(i)
Late submission of 15-day report
Cited by Scott N Lim, Cynthia J Tsui
17 Jul 2018
21 CFR 314.80(c)(1)(i)
Late submission of 15-day report
Cited by Diane C Van Leeuwen, Dustin R Abaonza
25 Jul 2014
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Walden H Lee, Ashar P Parikh, Jennifer H Rhyu
Investigators
FDA investigators tied to this site in the record.
Sandra S Saniga3 insp.
Ashar P Parikh3 insp.
Kevin P Foley3 insp.
Cynthia J Tsui2 insp.
Walden H Lee2 insp.
Jennifer H Rhyu2 insp.
Daniel J Roberts2 insp.
Kim L Thomas Cruse2 insp.
Lance M De Souza2 insp.
Christopher R Czajka1 insp.
Scott N Lim1 insp.
Kristin M Abaonza1 insp.
Diane C Van Leeuwen1 insp.
Dustin R Abaonza1 insp.
Anh Lac1 insp.
Sharon K Thoma1 insp.
Carl Lee1 insp.
Peter E Baker1 insp.
Jennifer L Johnson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 11 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.58(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Gilead Sciences, Inc.'s 13 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat