FDA Inspection
NIDEK Co., Ltd.NIDEK Co., Ltd. – FDA Inspection, Jun 1, 2017
Record Details
This FDA Inspection record concerns NIDEK Co., Ltd., with an inspection on June 1, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 91b7edb2-bf82-453b-ab84-49df61d8836d
Inspection Facts
- Inspection number
- 1013281
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of NIDEK Co., Ltd.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 14, 2018 | Not classified | Office of Inspections and Investigations | |
| December 8, 2017 | Not classified | Office of Inspections and Investigations | |
| July 31, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 18, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for NIDEK Co., Ltd.
- FDA Inspection 1132031 - 2018-09-14
- FDA Inspection 1079761 - 2017-12-08
- FDA Inspection 890755 - 2014-07-31
- FDA Inspection 653387 - 2010-02-18
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