FDA inspection
BEIJING SINCOHEREN SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD: FDA inspection ending Jan 18, 2018
FDA inspection 1039150 · Beijing
Key facts
| Inspection ID | 1039150 |
|---|---|
| Firm | BEIJING SINCOHEREN SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD |
| FEI number | 3006555617 |
| Address | Sinotrans Plaza Room 305, No. 43 Xizhimen North St.; Haidian District |
| City | Beijing |
| Fiscal year | 2018 |
| Inspection end date | Jan 18, 2018 |
| 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