Datex-Ohmeda, Inc
Form 483 issued June 12, 2015 · Madison, Wisconsin
- Inspection
- Apr 20 – Jun 12, 2015
- Investigators
- Jennifer S. Ness· Michelle J. Glembin
- Observations
- 8
- Pages
- 7
- FEI number
- 2112667
In short: On June 12, 2015, FDA issued a Form 483 with 8 observations to Datex-Ohmeda, Inc in Madison, Wisconsin (FEI 2112667) after an inspection that ran Apr 20 – Jun 12, 2015. The investigators were Jennifer S. Ness and Michelle J. Glembin. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
6 of 8 observations on this 483 concern capa.
Most cited: 21 CFR 820.198 (2×) · 820.90 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 02
Complaints involving the possible failure of a device to meet any of its specifications were…
- 03
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 04
Procedures for corrective and preventive action have…
This inspection in context
Jennifer S. Ness
5 documents · 2015–2019
Cites 820.90 (nonconforming product) more than any other section. Most of their documents are for sites in Wisconsin.
The firmDatex-Ohmeda, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Datex-Ohmeda, Inc?
FDA listed 8 observations on this Form 483, mostly about cAPA and production & process controls. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Datex-Ohmeda, Inc?
Jennifer S. Ness and Michelle J. Glembin are named on this Form 483, for the inspection of Apr 20 – Jun 12, 2015. Each investigator has a profile showing what they cite most.
When was Datex-Ohmeda, Inc inspected by FDA?
The inspection ran Apr 20 – Jun 12, 2015, and the Form 483 is dated June 12, 2015.
How do I get the full Form 483 for Datex-Ohmeda, Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.