Qualgen, LLC
FDA inspection history in Edmond, Oklahoma, 2015 to 2025
- 6
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2017: one Form 483; 2018: one Form 483; 2022: one Form 483; 2024: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–18Three Form 483s, at Edmond, Oklahoma.
- 2022–25Three Form 483s, at Edmond, Oklahoma.
- 2024The longest 483 on file: 14 observations over 15 pages at Edmond, Oklahoma.
Cited most
Across all Qualgen observations on file
- 21 CFR 211.113Control of microbiological contamination7
- 21 CFR 211.22Responsibilities of quality control unit6
- 21 CFR 211.42Design and construction features6
- 21 CFR 211.100Written procedures; deviations5
- 21 CFR 211.160General requirements5
The complete Qualgen file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Edmond, Oklahoma
Six Form 483s · 2015 to 2025 · 56 observations
Latest: Form 483, Sep 4, 2025 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-09-04 | 483 Form 483 | Edmond, Oklahoma | 5 | $99 |
| 2024-03-19 | 483 Form 483 | Edmond, Oklahoma | 14 | $99 |
| 2022-09-30 | 483 Form 483 | Edmond, Oklahoma | 9 | $99 |
| 2018-09-13 | 483 Form 483 | Edmond, Oklahoma | 9 | $99 |
| 2017-05-10 | 483 Form 483 | Edmond, Oklahoma | 5 | $99 |
| 2015-09-17 | 483 Form 483 | Edmond, Oklahoma | 14 | $99 |
Investigators on these documents
Margaret M. Annes (4)Logan T. Williams (1)Lisa Whitt (1)Patty P. Kaewussdangkul (1)Shawn E. Larson (1)Zachary L. Stamm (1)Michelle A. Krayer (1)
FEI number 3011286349 · most recent document Sep 4, 2025
About Qualgen, LLC
How many FDA Form 483s has Qualgen, LLC received?
FDA Intel has 6 Form 483s on file for Qualgen, LLC; the most recent is dated Sep 4, 2025.
When was Qualgen, LLC last inspected by FDA?
The most recent FDA inspection document on file for Qualgen, LLC is a Form 483 dated Sep 4, 2025, for the site in Edmond, Oklahoma.
What did FDA cite at Qualgen, LLC?
The regulations cited most in the observations on file for Qualgen, LLC are 21 CFR 211.113 (Control of microbiological contamination), 7 times; 21 CFR 211.22 (Responsibilities of quality control unit), 6 times; 21 CFR 211.42 (Design and construction features), 6 times.