Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-18.
At a glance
Inspections
5
Form 483s
4
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Feb 2026 – 18 Feb 2026 | Human Drugs | 483 | View 483 → |
| 5 Feb 2024 – 12 Feb 2024 | Human Drugs | 483 | View 483 → |
| 12 Sep 2022 – 16 Sep 2022 | Human Drugs | 483 | View 483 → |
| 6 Dec 2021 – 17 Dec 2021 | Human Drugs | 483 | View 483 → |
| 6 May 2019 – 14 May 2019 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Procedures for sterile drug products
Cited by Katherine E Jacobitz, Bryan L Mcguckin, Miguel A Martinez, Carolina D Vasquez, Youkeun Kim, Pearl C Ozuruigbo, Elvis Patel
Following/documenting laboratory controls
Cited by Katherine E Jacobitz, Bryan L Mcguckin, Miguel A Martinez, Carolina D Vasquez, Youkeun Kim, Pearl C Ozuruigbo, Elvis Patel
Scientifically sound laboratory controls
Cited by Katherine E Jacobitz, Bryan L Mcguckin, Miguel A Martinez, Carolina D Vasquez, Youkeun Kim, Pearl C Ozuruigbo, Elvis Patel
Sterility/pyrogens - test methods written, followed
Cited by Katherine E Jacobitz, Bryan L Mcguckin, Miguel A Martinez, Carolina D Vasquez, Youkeun Kim, Pearl C Ozuruigbo, Elvis Patel
Annual visual exams of drug products
Cited by Katherine E Jacobitz, Bryan L Mcguckin, Miguel A Martinez, Carolina D Vasquez, Youkeun Kim, Pearl C Ozuruigbo, Elvis Patel
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Gilead Sciences, Inc.'s 4 Form 483s
Source PDFs 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