QualgenLLC
Form 483 issued April 29, 2021 · Edmond, Oklahoma
- Inspection
- Apr 29, 2021
- Investigators
- Margaret M. Annes· Preston B. Hoover
- Observations
- 15
- Pages
- 13
In short: On April 29, 2021, FDA issued a Form 483 with 15 observations to QualgenLLC in Edmond, Oklahoma after an inspection that ran Apr 29, 2021. The investigators were Margaret M. Annes and Preston B. Hoover. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and production account for 10 of 15 observations.
Most cited: 21 CFR 211.67 (2×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish an adequate quality control unit with the responsibility and authority to…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
There are no written methods of cleaning or methods of processing…
- 04
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
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 firmQualgenLLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at QualgenLLC?
FDA listed 15 observations on this Form 483, mostly about facilities & equipment, production and packaging & labeling. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected QualgenLLC?
Margaret M. Annes and Preston B. Hoover are named on this Form 483, for the inspection of Apr 29, 2021. Each investigator has a profile showing what they cite most.
When was QualgenLLC inspected by FDA?
The inspection ran Apr 29, 2021, and the Form 483 is dated April 29, 2021.
How do I get the full Form 483 for QualgenLLC?
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.