QualgenLLC
FDA inspection history in Edmond, Oklahoma, 2021
- 1
- Form 483
Every document, by year
- Form 483
2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021One Form 483, at Edmond, Oklahoma.
Cited most
Across all QualgenLLC observations on file
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.160General requirements1
The complete QualgenLLC file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Edmond, Oklahoma
One Form 483 · 2021 · 15 observations
Latest: Form 483, Apr 29, 2021 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-04-29 | 483 Form 483 | Edmond, Oklahoma | 15 | $99 |
Investigators on these documents
About QualgenLLC
How many FDA Form 483s has QualgenLLC received?
FDA Intel has 1 Form 483 on file for QualgenLLC; the most recent is dated Apr 29, 2021.
When was QualgenLLC last inspected by FDA?
The most recent FDA inspection document on file for QualgenLLC is a Form 483 dated Apr 29, 2021, for the site in Edmond, Oklahoma.
What did FDA cite at QualgenLLC?
The regulations cited most in the observations on file for QualgenLLC are 21 CFR 211.42 (Design and construction features), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.