GenTrac Inc.
FDA inspection history in Middleton, Wisconsin, 2019
- 1
- Form 483
Every document, by year
- Form 483
2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Middleton, Wisconsin.
Cited most
Across all GenTrac observations on file
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.42Design and construction features1
- 21 CFR 211.56Sanitation1
The complete GenTrac file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Middleton, Wisconsin
One Form 483 · 2019 · 6 observations
Latest: Form 483, Sep 12, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-09-12 | 483 Form 483 | Middleton, Wisconsin | 6 | $99 |
Investigators on these documents
FEI number 3002919848 · most recent document Sep 12, 2019
About GenTrac Inc.
How many FDA Form 483s has GenTrac Inc. received?
FDA Intel has 1 Form 483 on file for GenTrac Inc.; the most recent is dated Sep 12, 2019.
When was GenTrac Inc. last inspected by FDA?
The most recent FDA inspection document on file for GenTrac Inc. is a Form 483 dated Sep 12, 2019, for the site in Middleton, Wisconsin.
What did FDA cite at GenTrac Inc.?
The regulations cited most in the observations on file for GenTrac Inc. are 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.166 (Stability testing), 1 time.