FDA inspection
Rayence Co. Ltd.: FDA inspection ending Sep 22, 2016
FDA inspection 987530 · Hwaseong
Key facts
| Inspection ID | 987530 |
|---|---|
| Firm | Rayence Co. Ltd. |
| FEI number | 3009048384 |
| Address | 14 Samseong1ro1-Gil |
| City | Hwaseong |
| Fiscal year | 2016 |
| Inspection end date | Sep 22, 2016 |
| 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 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No 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