FDA Inspection
Natus Medical IncorporatedNatus Medical Incorporated – FDA Inspection, Jul 27, 2016
Record Details
This FDA Inspection record concerns Natus Medical Incorporated, with an inspection on July 27, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Natus Medical Incorporated
- Inspection Date
- July 27, 2016
- Product Type
- Devices
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ID · f81a330d-4ec7-47e6-a989-aa8942796b2b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 982062
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
Showing 10 of 12 citations.
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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 |
| 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 1062328 - 2018-08-13
- FDA Inspection 1017171 - 2017-06-27
- FDA Inspection 898177 - 2014-09-10
- FDA Inspection 791200 - 2012-07-11
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