FDA inspection
NIDEK Co., Ltd.: FDA inspection ending May 23, 2013
FDA inspection 836571 · Administrative/Directed Change (ADC) · GAMAGORI
Key facts
| Inspection ID | 836571 |
|---|---|
| Firm | NIDEK Co., Ltd. |
| FEI number | 3002807715 |
| Address | 34-14 MAEHAMA, HIROISHI-CHO |
| City | GAMAGORI |
| Fiscal year | 2013 |
| Inspection end date | May 23, 2013 |
| Classification | Administrative/Directed Change (ADC) |
| Project area | Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority |
| Product type | Devices |
| Warning letter | 410944 |
At a glance
- 10–99 Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data