FDA Inspection
Nikao, Inc.Nikao, Inc. – FDA Inspection, Sep 12, 2012
Record Details
This FDA Inspection record concerns Nikao, Inc., with an inspection on September 12, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Nikao, Inc.
- Inspection Date
- September 12, 2012
- Product Type
- Devices
View Company Profile
ID · d2474bd4-2810-4fdf-9448-089f17fc90b3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 798551
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
Full citation text and observation details available on the Dashboard.
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 |
| 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 |
Other documents for Nikao, Inc.
- FDA Inspection 1163502 - 2022-02-18
- FDA Inspection 1003245 - 2017-02-01
- FDA Inspection 832321 - 2013-05-13
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