FDA Inspection
Nidek, Inc.Nidek, Inc. – FDA Inspection, Mar 7, 2012
Record Details
This FDA Inspection record concerns Nidek, Inc., with an inspection on March 7, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Nidek, Inc.
- Inspection Date
- March 7, 2012
- Product Type
- Devices
View Company Profile
ID · e8866bdc-aa1f-4516-be70-e63339dbbb11
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 770985
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(b)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Nidek, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 24, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 31, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 10, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 10, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 14, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Nidek, Inc.
- FDA Inspection 1078121 - 2019-01-24
- FDA Inspection 1009390 - 2017-03-31
- FDA Inspection 980717 - 2016-08-10
- FDA Inspection 930830 - 2015-06-10
- FDA Inspection 871244 - 2014-04-14
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