Trokamed GmbH
FDA inspection history in Geisingen, Germany, 2013 to 2016
- 1
- Close-out
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2013: one warning letter; 2016: one close-out letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013One warning letter, at Geisingen, Germany.
- 2016One close-out letter and one Form 483, at Geisingen, Germany.
Cited most
Across all Trokamed observations on file
- 21 CFR 820.100(b)Corrective and preventive action1
The complete Trokamed file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Geisingen, Germany
One Form 483 and one warning letter · 2013 to 2016 · 1 observation
Latest: Form 483, Feb 19, 2016 →
Also: one document not tied to a site.
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-05-18 | Close-out Close-out letter | — | — | $99 |
| 2016-02-19 | 483 Form 483 | Geisingen, Germany | 1 | $99 |
| 2013-11-22 | Warning letter Warning letter | Geisingen, Germany | — | $99 |
Investigators on these documents
FEI number 3004595684 · most recent document May 18, 2016
About Trokamed GmbH
How many FDA Form 483s has Trokamed GmbH received?
FDA Intel has 1 Form 483 on file for Trokamed GmbH; the most recent is dated Feb 19, 2016.
When was Trokamed GmbH last inspected by FDA?
The most recent FDA inspection document on file for Trokamed GmbH is a Form 483 dated Feb 19, 2016, for the site in Geisingen, Germany.
What did FDA cite at Trokamed GmbH?
The regulations cited most in the observations on file for Trokamed GmbH are 21 CFR 820.100(b) (Corrective and preventive action), 1 time.
Has Trokamed GmbH received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Trokamed GmbH; the most recent is dated Nov 22, 2013.