FDA Inspection
Nikao, Inc.Nikao, Inc. – FDA Inspection, Feb 1, 2017
Record Details
This FDA Inspection record concerns Nikao, Inc., with an inspection on February 1, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e77b39de-485f-4b41-9495-27d5a8330b50
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1003245
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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Other FDA inspections of Nikao, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 18, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 13, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 12, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Nikao, Inc.
- FDA Inspection 1163502 - 2022-02-18
- FDA Inspection 832321 - 2013-05-13
- FDA Inspection 798551 - 2012-09-12
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