Qualgen, LLC
Form 483 issued September 4, 2025 · Edmond, Oklahoma
- Inspection
- Sep 4, 2025
- Investigators
- Logan T. Williams· Zachary L. Stamm
- Observations
- 5
- Pages
- 9
- FEI number
- 3011286349
In short: On September 4, 2025, FDA issued a Form 483 with 5 observations to Qualgen, LLC in Edmond, Oklahoma (FEI 3011286349) after an inspection that ran Sep 4, 2025. The investigators were Logan T. Williams and Zachary L. Stamm. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 3 of 5 observations.
Most cited: 21 CFR 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is insufficient physical or spatial separation from operations and other drug products to…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
The quality control unit lacks responsibility to reject all procedures or specifications impacting on the identity…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Logan T. Williams
32 documents · 2020–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kentucky.
The firmQualgen, LLC history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Qualgen, LLC?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Qualgen, LLC?
Logan T. Williams and Zachary L. Stamm are named on this Form 483, for the inspection of Sep 4, 2025. Each investigator has a profile showing what they cite most.
When was Qualgen, LLC inspected by FDA?
The inspection ran Sep 4, 2025, and the Form 483 is dated September 4, 2025.
How do I get the full Form 483 for Qualgen, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.