Datex-Ohmeda, Inc
FDA inspection history in Madison, Wisconsin, 2015
- 1
- Form 483
Every document, by year
- Form 483
2015: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Madison, Wisconsin.
Cited most
Across all Datex-Ohmeda observations on file
- 21 CFR 820.198Complaint files2
- 21 CFR 820.90Nonconforming product2
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 820.100Corrective and preventive action1
- 21 CFR 820.200Servicing1
The complete Datex-Ohmeda file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Madison, Wisconsin
One Form 483 · 2015 · 8 observations
Latest: Form 483, Jun 12, 2015 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-06-12 | 483 Form 483 | Madison, Wisconsin | 8 | $99 |
Investigators on these documents
FEI number 2112667 · most recent document Jun 12, 2015
About Datex-Ohmeda, Inc
How many FDA Form 483s has Datex-Ohmeda, Inc received?
FDA Intel has 1 Form 483 on file for Datex-Ohmeda, Inc; the most recent is dated Jun 12, 2015.
When was Datex-Ohmeda, Inc last inspected by FDA?
The most recent FDA inspection document on file for Datex-Ohmeda, Inc is a Form 483 dated Jun 12, 2015, for the site in Madison, Wisconsin.
What did FDA cite at Datex-Ohmeda, Inc?
The regulations cited most in the observations on file for Datex-Ohmeda, Inc are 21 CFR 820.198 (Complaint files), 2 times; 21 CFR 820.90 (Nonconforming product), 2 times; 21 CFR 803.50 (If I am a manufacturer, what reporting requirements apply to me?), 1 time.