Company
JapanNIDEK Co., Ltd., Gamagoori, Japan – FDA Inspections
Inspection records and compliance data for NIDEK Co., Ltd. in Gamagoori. 5 FDA inspections on record, 3 Form 483s, last inspected September 14, 2018.
Company Profile
This profile covers NIDEK Co., Ltd. based in Gamagoori, Japan.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 3
- Form 483s
- 3
- Warning letters
- 0
First inspected February 18, 2010. Last inspected September 14, 2018.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Environmental control Lack of or inadequate procedures1 inspection
- Investigation of device failures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 14, 2018 | Not classified | Medical Devices & Rad Health | 1132031 |
| December 8, 2017 | Not classified | Medical Devices & Rad Health | 1079761 |
| June 1, 2017 | Not classified | Medical Devices & Rad Health · Project Evaluation: Devices | 1013281 |
| July 31, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 890755 |
| February 18, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 653387 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
NIDEK Co., Ltd.
FEI Number
3002807715
Address
34-14, Hiroishi-Cho, Gamagoori, Japan
Country
Japan
ID: d2c1c127-d4a8-47b8-817c-27d56c77492e