Qualgen, LLC
Form 483 issued September 17, 2015 · Edmond, Oklahoma
- Inspection
- Aug 24 – Sep 17, 2015
- Investigator
- Shawn E. Larson
- Observations
- 14
- Pages
- 14
- FEI number
- 3011286349
In short: On September 17, 2015, FDA issued a Form 483 with 14 observations to Qualgen, LLC in Edmond, Oklahoma (FEI 3011286349) after an inspection that ran Aug 24 – Sep 17, 2015. The investigator was Shawn E. Larson. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The separate or defined areas and control systems necessary to prevent contamination…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Drug product containers and closures were not clean and sterilized and processed to remove pyrogenic properties…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Shawn E. Larson
8 documents · 2015–2020
Cites 211.160(a) (general requirements) 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 211.42(c)
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 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Qualgen, LLC?
Shawn E. Larson is named on this Form 483, for the inspection of Aug 24 – Sep 17, 2015. Each investigator has a profile showing what they cite most.
When was Qualgen, LLC inspected by FDA?
The inspection ran Aug 24 – Sep 17, 2015, and the Form 483 is dated September 17, 2015.
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.