Qualgen, LLC
Form 483 issued September 30, 2022 · Edmond, Oklahoma
- Inspection
- Sep 13 – Sep 30, 2022
- Investigators
- Margaret M. Annes· Patty P. Kaewussdangkul
- Observations
- 9
- Pages
- 8
- FEI number
- 3011286349
In short: On September 30, 2022, FDA issued a Form 483 with 9 observations to Qualgen, LLC in Edmond, Oklahoma (FEI 3011286349) after an inspection that ran Sep 13 – Sep 30, 2022. The investigators were Margaret M. Annes and Patty P. Kaewussdangkul. Most observations concern production and quality system.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Written procedures are not followed that describe the examinations to be conducted on appropriate samples of…
- 03
Dmg products failing to meet established…
- 04
Procedures describing the handling of all written and oral complaints regarding a drug…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
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(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Qualgen, LLC?
FDA listed 9 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Qualgen, LLC?
Margaret M. Annes and Patty P. Kaewussdangkul are named on this Form 483, for the inspection of Sep 13 – Sep 30, 2022. Each investigator has a profile showing what they cite most.
When was Qualgen, LLC inspected by FDA?
The inspection ran Sep 13 – Sep 30, 2022, and the Form 483 is dated September 30, 2022.
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.