FDA Inspection
Nidek Medical Products IncNidek Medical Products Inc – FDA Inspection, Apr 10, 2012
Record Details
This FDA Inspection record concerns Nidek Medical Products Inc, with an inspection on April 10, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Nidek Medical Products Inc
- Inspection Date
- April 10, 2012
- Product Type
- Devices
View Company Profile
ID · a707df96-3472-4c78-a0e6-26e93b270d0c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 775100
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
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 |
| February 24, 2010 | VAI | 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 650979 - 2010-02-24
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