FDA Inspection
Natus Medical IncorporatedNatus Medical Incorporated – FDA Inspection, Aug 13, 2018
Record Details
This FDA Inspection record concerns Natus Medical Incorporated, with an inspection on August 13, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 99d48370-18fe-4440-89d7-67f7893545f4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1062328
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 803.50(a)(2)Individual Report of Malfunction
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Natus Medical Incorporated
9| Date | Classification | Office | Project area |
|---|---|---|---|
| October 5, 2018 | Not classified | Seattle District Office | |
| June 27, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 27, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 10, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 11, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Natus Medical Incorporated
- FDA Inspection 1122379 - 2018-10-05
- FDA Inspection 1017171 - 2017-06-27
- FDA Inspection 982062 - 2016-07-27
- FDA Inspection 898177 - 2014-09-10
- FDA Inspection 791200 - 2012-07-11
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.