Roche Diagnostics GmbH
FDA inspection history in Mannheim, Germany, 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 Mannheim, Germany.
Cited most
Across all Roche Diagnostics observations on file
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?1
The complete Roche Diagnostics file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Mannheim, Germany
One Form 483 · 2019 · 1 observation
Latest: Form 483, Aug 29, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-08-29 | 483 Form 483 | Mannheim, Germany | 1 | $99 |
FEI number 3002806559 · most recent document Aug 29, 2019
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 Aug 29, 2019.
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 Aug 29, 2019, for the site in Mannheim, 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 803.50 (If I am a manufacturer, what reporting requirements apply to me?), 1 time.