Overview
- 15 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-03.
At a glance
Inspections
15
Form 483s
6
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Feb 2026 – 3 Mar 2026 | Human Drugs | Clean | |
| 18 Jul 2024 – 1 Aug 2024 | Human Drugs | Clean | |
| 18 Apr 2023 – 4 May 2023 | Human Drugs | 483 | View 483 → |
| 15 Aug 2022 – 19 Aug 2022 | Human Drugs | Clean | |
| 2 Oct 2017 – 5 Oct 2017 | Human Drugs | Clean | |
| 28 Aug 2017 – 7 Sep 2017 | Human Drugs | 483 | View 483 → |
| 12 Sep 2016 – 21 Sep 2016 | Human Drugs | 483 | View 483 → |
| 21 Apr 2015 – 29 Apr 2015 | Human Drugs | Clean | |
| 11 Feb 2015 – 17 Feb 2015 | Human Drugs | Clean | |
| 24 Sep 2014 – 16 Oct 2014 | Human Drugs | 483 | View 483 → |
| 2 Aug 2012 | Not recorded | 483 | On file |
| 13 Jan 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Sep 2017
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Sean R Marcsisin, Christina A Capacci-Daniel, Yong Hu, Sharmista Chatterjee
7 Sep 2017
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Sean R Marcsisin, Christina A Capacci-Daniel, Yong Hu, Sharmista Chatterjee
7 Sep 2017
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Sean R Marcsisin, Christina A Capacci-Daniel, Yong Hu, Sharmista Chatterjee
7 Sep 2017
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Sean R Marcsisin, Christina A Capacci-Daniel, Yong Hu, Sharmista Chatterjee
Investigators
FDA investigators tied to this site in the record.
Edmund F Mrak2 insp.
Robert J Martin2 insp.
Sean R Marcsisin2 insp.
Armen H Youssoufian1 insp.
Meredith L Miller1 insp.
Shirley S Wen1 insp.
Craig T Rybus1 insp.
Christina A Capacci-Daniel1 insp.
Yong Hu1 insp.
Sharmista Chatterjee1 insp.
Vioela J Caze1 insp.
Kenneth H Williams1 insp.
Samina S Khan1 insp.
Patric C Klotzbuecher1 insp.
Arie Menachem1 insp.
Darin S Wiegers1 insp.
Camerson E Moore1 insp.
Paraluman S Leonin1 insp.
Sandra P White1 insp.
Douglas Fiorentino1 insp.
Pamela L Ogonowski1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Vertex Pharmaceuticals Incorporated's 6 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