Company
ChinaChangzhou Orthmed Medical Instrument Co., Ltd., Changzhou, China – FDA Inspections
Inspection records and compliance data for Changzhou Orthmed Medical Instrument Co., Ltd. in Changzhou. 2 FDA inspections on record, 1 Form 483, last inspected May 19, 2017.
Company Profile
This profile covers Changzhou Orthmed Medical Instrument Co., Ltd. based in Changzhou, China.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected May 30, 2013. Last inspected May 19, 2017.
Most cited issue areas
- Documentation1 inspection
- Procedures not adequately established or maintained1 inspection
- Production and Process Change Procedures, lack of or Inad.1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 19, 2017 | Not classified | Medical Devices & Rad Health | 1015340 |
| May 30, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 838678 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD
JIE GAO PLASTIC PRODUCTS CO., LTD.
Jinan Sign CNC Equipment Co Ltd
E-M Medical Treatment And Electron (Suzhou) Co Ltd
ARC Medical Supplies (Beijing) Co., Ltd.
MED&CARE (SHENZHEN) CO., LTD.
GN Resound China, Ltd.
Shenzhen Poda Laser Technology Co. Ltd.
Chongqing Xinfeng Medical Instruments Co., Ltd.
Goldensign International Technology Co.Ltd
Company Information
Name
Changzhou Orthmed Medical Instrument Co., Ltd.
FEI Number
3005596372
Address
NO. 177 Qinlinglu, Xinbei, Changzhou, China
Country
China
ID: abdd7e9c-eaa8-4b9f-9093-47bb531afa25