Overview
- 12 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-04-26.
At a glance
Inspections
12
Form 483s
2
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Apr 2018 – 26 Apr 2018 | Human Drugs | Clean | |
| 11 Jan 2016 – 19 Jan 2016 | Human Drugs | Clean | |
| 22 Sep 2014 – 26 Sep 2014 | Human Drugs | Clean | |
| 7 May 2014 – 16 May 2014 | Human Drugs | 483 | View 483 → |
| 31 Jul 2013 – 7 Aug 2013 | Human Drugs | Clean | |
| 3 Aug 2012 | Not recorded | Clean | |
| 7 Dec 2010 | Not recorded | Clean | |
| 12 Feb 2010 | Not recorded | 483 | View 483 → |
| 30 Jun 2008 | Not recorded | Clean | |
| 4 Oct 2005 | Not recorded | Clean | |
| 8 Oct 2004 | Not recorded | Clean | |
| 25 Aug 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 May 2014
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Liming Zhang, Katherine E Jacobitz, Linda Thai, Brian J Ryan
16 May 2014
21 CFR 211.42(c)(10)(iii)
Air Supply
Cited by Liming Zhang, Katherine E Jacobitz, Linda Thai, Brian J Ryan
16 May 2014
21 CFR 211.115(a)
Reprocessing procedures lack steps to be taken
Cited by Liming Zhang, Katherine E Jacobitz, Linda Thai, Brian J Ryan
16 May 2014
21 CFR 211.130(b)
Unlabeled filled containers controls
Cited by Liming Zhang, Katherine E Jacobitz, Linda Thai, Brian J Ryan
16 May 2014
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Liming Zhang, Katherine E Jacobitz, Linda Thai, Brian J Ryan
Investigators
FDA investigators tied to this site in the record.
Caryn M Mcnab3 insp.
Jennifer M Gogley2 insp.
Jamie M Du2 insp.
Carla J Lundi2 insp.
John A Gonzalez1 insp.
Arie Menachem1 insp.
Tajah L Blackburn1 insp.
Liming Zhang1 insp.
Katherine E Jacobitz1 insp.
Linda Thai1 insp.
Brian J Ryan1 insp.
Matthew J Johnson1 insp.
Joey V Quitania1 insp.
Marcus F Yambot1 insp.
Thao T Kwan1 insp.
Donna M Williams Hill1 insp.
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 211.115(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Gilead Sciences Inc's 2 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