Roche Diagnostics Operations, Inc
FDA inspection history in Indianapolis, Indiana, 2016
- 1
- Form 483
Every document, by year
- Form 483
2016: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Indianapolis, Indiana.
Cited most
Across all Roche Diagnostics Operations observations on file
- 21 CFR 806.10(a)(1)Reports of corrections and removals1
The complete Roche Diagnostics Operations file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Indianapolis, Indiana
One Form 483 · 2016 · 1 observation
Latest: Form 483, Aug 15, 2016 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-08-15 | 483 Form 483 | Indianapolis, Indiana | 1 | $99 |
Investigators on these documents
FEI number 1823260 · most recent document Aug 15, 2016
About Roche Diagnostics Operations, Inc
How many FDA Form 483s has Roche Diagnostics Operations, Inc received?
FDA Intel has 1 Form 483 on file for Roche Diagnostics Operations, Inc; the most recent is dated Aug 15, 2016.
When was Roche Diagnostics Operations, Inc last inspected by FDA?
The most recent FDA inspection document on file for Roche Diagnostics Operations, Inc is a Form 483 dated Aug 15, 2016, for the site in Indianapolis, Indiana.
What did FDA cite at Roche Diagnostics Operations, Inc?
The regulations cited most in the observations on file for Roche Diagnostics Operations, Inc are 21 CFR 806.10(a)(1) (Reports of corrections and removals), 1 time.