Qualgen, LLC
Form 483 issued May 10, 2017 · Edmond, Oklahoma
- Inspection
- Apr 17 – May 10, 2017
- Investigator
- Margaret M. Annes
- Observations
- 5
- Pages
- 5
- FEI number
- 3011286349
In short: On May 10, 2017, FDA issued a Form 483 with 5 observations to Qualgen, LLC in Edmond, Oklahoma (FEI 3011286349) after an inspection that ran Apr 17 – May 10, 2017. The investigator was Margaret M. Annes. Most observations concern production and quality system.
At a glance
Production and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
The separate or defined areas and control systems necessary to prevent contamination…
- 04
Written procedures are not established and followed that describe the in-process controls, tests and examinations to…
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Qualgen, LLC?
FDA listed 5 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Qualgen, LLC?
Margaret M. Annes is named on this Form 483, for the inspection of Apr 17 – May 10, 2017. Each investigator has a profile showing what they cite most.
When was Qualgen, LLC inspected by FDA?
The inspection ran Apr 17 – May 10, 2017, and the Form 483 is dated May 10, 2017.
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.