Qualgen, LLC
Form 483 issued March 19, 2024 · Edmond, Oklahoma
- Inspection
- Feb 6 – Mar 19, 2024
- Investigators
- Margaret M. Annes· Michelle A. Krayer
- Observations
- 14
- Pages
- 15
- FEI number
- 3011286349
In short: On March 19, 2024, FDA issued a Form 483 with 14 observations to Qualgen, LLC in Edmond, Oklahoma (FEI 3011286349) after an inspection that ran Feb 6 – Mar 19, 2024. The investigators were Margaret M. Annes and Michelle A. Krayer. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 9 of 14 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Procedures describing the handling of all written and oral complaints regarding a drug product are…
- 03
EMPI.OYEE(S) SIGNATURE There is a failure to thoroughly review any unexplained discrepancy and the failure of…
- 04
Your firm failed to establish written procedures for production and process controls designed to assure that…
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Qualgen, LLC?
FDA listed 14 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Qualgen, LLC?
Margaret M. Annes and Michelle A. Krayer are named on this Form 483, for the inspection of Feb 6 – Mar 19, 2024. Each investigator has a profile showing what they cite most.
When was Qualgen, LLC inspected by FDA?
The inspection ran Feb 6 – Mar 19, 2024, and the Form 483 is dated March 19, 2024.
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.