Overview
- 11 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-07.
At a glance
Inspections
11
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Mar 2025 – 7 Mar 2025 | Human Drugs | WL | On file |
| 11 Feb 2019 – 12 Feb 2019 | Medical Devices & Rad Health | Clean | |
| 8 Feb 2018 – 13 Feb 2018 | Foods & Cosmetics | Clean | |
| 27 Aug 2015 – 4 Sep 2015 | Medical Devices & Rad Health | Clean | |
| 21 Oct 2013 – 12 Nov 2013 | Human Drugs | 483 | View 483 → |
| 11 Jul 2012 | Not recorded | 483 | View 483 → |
| 12 Oct 2011 | Not recorded | 483 | View 483 → |
| 14 Jun 2011 | Not recorded | 483 | View 483 → |
| 7 Jul 2008 | Not recorded | Clean | |
| 14 Feb 2005 | Not recorded | Clean | |
| 21 Jul 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Nov 2013
21 CFR 211.22(b)
Adequate lab facilities not available
Cited by Michelle J Glembin, Sandra A Hughes
12 Nov 2013
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Michelle J Glembin, Sandra A Hughes
12 Nov 2013
21 CFR 211.67(b)
Written procedures fail to include
Cited by Michelle J Glembin, Sandra A Hughes
12 Nov 2013
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Michelle J Glembin, Sandra A Hughes
12 Nov 2013
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Michelle J Glembin, Sandra A Hughes
Investigators
FDA investigators tied to this site in the record.
Sandra A Hughes3 insp.
Melissa J Holz2 insp.
Melissa M Steiger1 insp.
Nicholas Z Lu1 insp.
Alecia L Marson1 insp.
Denise L Burosh1 insp.
Rafael A Kaup1 insp.
Michelle J Glembin1 insp.
Sarah A Palmer1 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 211.165(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.113(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Wisconsin Pharmacal Company, LLC'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