Transtracheal Systems, Inc
FDA inspection history in Englewood, Colorado, 2020
- 1
- Form 483
Every document, by year
- Form 483
2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at Englewood, Colorado.
Cited most
Across all Transtracheal Systems observations on file
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.120Device labeling1
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.40Document controls1
- 21 CFR 820.50Purchasing controls1
The complete Transtracheal Systems file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Englewood, Colorado
One Form 483 · 2020 · 4 observations
Latest: Form 483, Sep 17, 2020 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-09-17 | 483 Form 483 | Englewood, Colorado | 4 | $99 |
Investigators on these documents
FEI number 1721097 · most recent document Sep 17, 2020
About Transtracheal Systems, Inc
How many FDA Form 483s has Transtracheal Systems, Inc received?
FDA Intel has 1 Form 483 on file for Transtracheal Systems, Inc; the most recent is dated Sep 17, 2020.
When was Transtracheal Systems, Inc last inspected by FDA?
The most recent FDA inspection document on file for Transtracheal Systems, Inc is a Form 483 dated Sep 17, 2020, for the site in Englewood, Colorado.
What did FDA cite at Transtracheal Systems, Inc?
The regulations cited most in the observations on file for Transtracheal Systems, Inc are 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.120 (Device labeling), 1 time; 21 CFR 820.198(a) (Complaint files), 1 time.