Roche Diagnostics GmbH
FDA inspection history across 2 sites, 2003 to 2023
- 2
- Warning letters
- 1
- Form 483
Every document, by year
- Form 483
- Warning letter
2003: one warning letter; 2004: one warning letter; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2003–04Two warning letters, at Indianapolis, Indiana.
- 2023One Form 483, at Penzberg, Germany.
Cited most
Across all Roche Diagnostics observations on file
- 21 CFR 211.182Equipment cleaning and use log1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
The complete Roche Diagnostics 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
Indianapolis, Indiana
Two warning letters · 2003 to 2004
Latest: Warning letter, Sep 2, 2004 →Penzberg, Germany
One Form 483 · 2023 · 2 observations
Latest: Form 483, Mar 10, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-03-10 | 483 Form 483 | Penzberg, Germany | 2 | $99 |
| 2004-09-02 | Warning letter Warning letter | Indianapolis, Indiana | — | $99 |
| 2003-02-05 | Warning letter Warning letter | Indianapolis, Indiana | — | $99 |
Investigators on these documents
FEI number 3002806560 · most recent document Mar 10, 2023
About Roche Diagnostics GmbH
How many FDA Form 483s has Roche Diagnostics GmbH received?
FDA Intel has 1 Form 483 on file for Roche Diagnostics GmbH; the most recent is dated Mar 10, 2023.
When was Roche Diagnostics GmbH last inspected by FDA?
The most recent FDA inspection document on file for Roche Diagnostics GmbH is a Form 483 dated Mar 10, 2023, for the site in Penzberg, Germany.
What did FDA cite at Roche Diagnostics GmbH?
The regulations cited most in the observations on file for Roche Diagnostics GmbH are 21 CFR 211.182 (Equipment cleaning and use log), 1 time; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 1 time.
Has Roche Diagnostics GmbH received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Roche Diagnostics GmbH; the most recent is dated Sep 2, 2004.