FDA Inspection
Nidek, Inc.Nidek, Inc. – FDA Inspection, Jul 30, 2013
Record Details
This FDA Inspection record concerns Nidek, Inc., with an inspection on July 30, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Nidek, Inc.
- Inspection Date
- July 30, 2013
- Product Type
- Devices
View Company Profile
ID · e5ead85b-5f71-4396-b4df-3abd805cb218
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 842321
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance 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, 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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