Overview
- 7 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-04.
At a glance
Inspections
7
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Aug 2025 – 4 Sep 2025 | Human Drugs | 483 | View 483 → |
| 6 Feb 2024 – 19 Mar 2024 | Human Drugs | 483 | View 483 → |
| 13 Sep 2022 – 30 Sep 2022 | Human Drugs | 483 | View 483 → |
| 29 Apr 2021 – 15 Jun 2021 | Human Drugs | 483 | On file |
| 8 Aug 2018 – 13 Sep 2018 | Human Drugs | 483 | On file |
| 17 Apr 2017 – 10 May 2017 | Human Drugs | 483 | View 483 → |
| 24 Aug 2015 – 17 Sep 2015 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Sep 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Zachary L Stamm, Logan T Williams
4 Sep 2025
21 CFR 211.130(a)
Prevention of cross contamination, mix-ups
Cited by Zachary L Stamm, Logan T Williams
4 Sep 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Zachary L Stamm, Logan T Williams
4 Sep 2025
21 CFR 211.22(c)
Approve or reject procedures or specs
Cited by Zachary L Stamm, Logan T Williams
4 Sep 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Zachary L Stamm, Logan T Williams
Investigators
FDA investigators tied to this site in the record.
Margaret M Annes6 insp.
Zachary L Stamm1 insp.
Logan T Williams1 insp.
Michelle A Krayer1 insp.
Patty P Kaewussdangkul1 insp.
Preston B Hoover1 insp.
Lisa R Whitt1 insp.
Shawn E Larson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 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 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 2x |
| FDCA 503B(a)(10) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.196 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Qualgen, LLC's 7 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