FDA Inspection
Nikao, Inc.Nikao, Inc. – FDA Inspection, Feb 18, 2022
Record Details
This FDA Inspection record concerns Nikao, Inc., with an inspection on February 18, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Nikao, Inc.
- Inspection Date
- February 18, 2022
- Product Type
- Devices
View Company Profile
ID · 4881e54f-f2ae-4756-aa8d-478e98e12db1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1163502
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Nikao, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2017 | VAI | Center for Devices and Radiological Health | Compliance: 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 1003245 - 2017-02-01
- FDA Inspection 832321 - 2013-05-13
- FDA Inspection 798551 - 2012-09-12
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