Qualgen, LLC
Form 483 issued September 13, 2018 · Edmond, Oklahoma
- Inspection
- Aug 8 – Sep 13, 2018
- Investigators
- Lisa Whitt· Margaret M. Annes
- Observations
- 9
- Pages
- 10
- FEI number
- 30112866349
In short: On September 13, 2018, FDA issued a Form 483 with 9 observations to Qualgen, LLC in Edmond, Oklahoma (FEI 30112866349) after an inspection that ran Aug 8 – Sep 13, 2018. The investigators were Lisa Whitt and Margaret M. Annes. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.100 (3×) · 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
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
This inspection in context
Lisa Whitt
3 documents · 2018–2020
Cites 211.100 (written procedures; deviations) 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 211.100
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 facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Qualgen, LLC?
Lisa Whitt and Margaret M. Annes are named on this Form 483, for the inspection of Aug 8 – Sep 13, 2018. Each investigator has a profile showing what they cite most.
When was Qualgen, LLC inspected by FDA?
The inspection ran Aug 8 – Sep 13, 2018, and the Form 483 is dated September 13, 2018.
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.