Overview
- 17 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-20.
At a glance
Inspections
17
Form 483s
8
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Mar 2026 – 20 Mar 2026 | Human Drugs | 483 | View 483 → |
| 19 Mar 2025 – 26 Mar 2025 | Human Drugs | 483 | On file |
| 3 Apr 2023 – 7 Apr 2023 | Human Drugs | Clean | |
| 6 Jan 2020 – 8 Jan 2020 | Human Drugs | Clean | |
| 4 Feb 2019 – 8 Feb 2019 | Human Drugs | 483 | View 483 → |
| 17 Jan 2018 – 26 Jan 2018 | Human Drugs | 483 | View 483 → |
| 26 Oct 2016 – 10 Nov 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Jul 2016 – 15 Jul 2016 | Human Drugs | Clean | |
| 23 Feb 2015 – 27 Feb 2015 | Human Drugs | Clean | |
| 4 Jun 2012 | Not recorded | 483 | View 483 → |
| 10 May 2011 | Not recorded | Clean | |
| 29 Apr 2011 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Mar 2026
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Anna M Spiros, Abigail Sundberg
20 Mar 2026
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Anna M Spiros, Abigail Sundberg
Investigators
FDA investigators tied to this site in the record.
Michael P Sheehan3 insp.
Tracey L Harris3 insp.
Lauren N Howard2 insp.
Teresa K Kastner2 insp.
Anna M Brannen2 insp.
Elizabeth L Edwards2 insp.
Anna M Spiros1 insp.
Abigail Sundberg1 insp.
Young K Chou1 insp.
Lisa R Hilliard1 insp.
Wen Ning Chan1 insp.
Sydney S Choi1 insp.
Jon P Antoniou1 insp.
James Norman1 insp.
Lindsey M Schwierjohann1 insp.
Kenneth E Felkley1 insp.
Nicholas L Paulin1 insp.
Christina L Bigham1 insp.
Joshua P Wireman1 insp.
David S Jackson1 insp.
Joshua S Hunt1 insp.
Christopher T Middendorf1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Teva Womens Health, LLC's 8 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