FDA inspection
Nidek, Inc.: FDA inspection ending Dec 15, 2005
FDA inspection 408266 · Voluntary Action Indicated (VAI) · Fremont, CA
Key facts
| Inspection ID | 408266 |
|---|---|
| Firm | Nidek, Inc. |
| FEI number | 2936921 |
| Address | 47651 Westinghouse Dr |
| City | Fremont |
| State | CA |
| ZIP | 94539-7474 |
| Fiscal year | 2006 |
| Inspection end date | Dec 15, 2005 |
| Classification | Voluntary Action Indicated (VAI) |
| 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 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Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth |
| Product type | Devices |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 10–99 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