Overview
- 9 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-09.
At a glance
Inspections
9
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Sep 2025 – 9 Sep 2025 | Human Drugs | Clean | |
| 26 Sep 2023 – 29 Sep 2023 | Human Drugs | 483 | View 483 → |
| 13 Dec 2021 – 16 Dec 2021 | Human Drugs | Clean | |
| 2 Dec 2010 | Not recorded | 483 | View 483 → |
| 1 Mar 2010 | Not recorded | 483 | View 483 → |
| 14 Aug 2009 | Not recorded | 483 | View 483 → |
| 31 Jul 2008 | Not recorded | 483 | On file |
| 24 May 2007 | Not recorded | Clean | |
| 20 Jan 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Sep 2023
FDCA 505-1(f)(4)
Failure to comply with REMS Implementation System
Cited by Michael Serrano, Ashley J Burns, Mayar M Mussa
1 Mar 2010
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Gayle S Lawson, Linda M Hoover
Investigators
FDA investigators tied to this site in the record.
Gayle S Lawson4 insp.
Michael Serrano2 insp.
Jay B Shah1 insp.
Ashley J Burns1 insp.
Mayar M Mussa1 insp.
Kent A Conforti1 insp.
Linda M Hoover1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(2)(i) | Cited across public-safe Form 483 observations | 1x |
| FDCA 505-1(f)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Teva Pharmaceuticals USA, Inc's 5 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