FDA Inspection
Natus Medical IncorporatedNatus Medical Incorporated – FDA Inspection, Oct 8, 2008
Record Details
This FDA Inspection record concerns Natus Medical Incorporated, with an inspection on October 8, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Natus Medical Incorporated
- Inspection Date
- October 8, 2008
- Product Type
- Devices
View Company Profile
ID · 4e8f2b07-e0a3-478f-97c3-871c5c0237be
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 542580
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.184(d)Acceptance records
- 21 CFR 820.72(b)(2)Calibration documentation
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 | |
| August 13, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| 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 |
Other documents for Natus Medical Incorporated
- FDA Inspection 1122379 - 2018-10-05
- FDA Inspection 1062328 - 2018-08-13
- FDA Inspection 1017171 - 2017-06-27
- FDA Inspection 982062 - 2016-07-27
- FDA Inspection 898177 - 2014-09-10
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