FDA Inspection
Nidek Medical Products IncNidek Medical Products Inc – FDA Inspection, Feb 24, 2010
Record Details
This FDA Inspection record concerns Nidek Medical Products Inc, with an inspection on February 24, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Nidek Medical Products Inc
- Inspection Date
- February 24, 2010
- Product Type
- Devices
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ID · d6ba1a14-3b04-49ab-bd8a-320d18682af1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 650979
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.198(a)General
- 21 CFR 820.198(a)Complete files maintained
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Nidek Medical Products Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 19, 2017 | Not classified | New Orleans District Office | |
| August 16, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 20, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 10, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Nidek Medical Products Inc
- FDA Inspection 1042510 - 2017-10-19
- FDA Inspection 985390 - 2016-08-16
- FDA Inspection 855858 - 2013-11-20
- FDA Inspection 775100 - 2012-04-10
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