Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-06-01.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Apr 2023 – 1 Jun 2023 | Human Drugs | 483 | On file |
| 30 Aug 2021 – 14 Sep 2021 | Human Drugs | WL | View 483 → |
| 7 May 2019 – 28 May 2019 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Sep 2021
21 CFR 211.160(a)
Lab controls established, including changes
Cited by David A Oluwo, Lauren N Barber
14 Sep 2021
21 CFR 211.180(e)(2)
Items to cover on annual reviews
Cited by David A Oluwo, Lauren N Barber
14 Sep 2021
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by David A Oluwo, Lauren N Barber
Investigators
FDA investigators tied to this site in the record.
Daniel L Zheng1 insp.
Lori M Newman1 insp.
David A Oluwo1 insp.
Lauren N Barber1 insp.
Erik W Koester1 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 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | 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)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind W.S. BADGER COMPANY, INC.'s 3 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