Company
ChinaOmron (Dalian) Co., Ltd. (Plant 1), Dalian, China – FDA Inspections
Inspection records and compliance data for Omron (Dalian) Co., Ltd. (Plant 1) in Dalian. 3 FDA inspections on record (1 OAI), last inspected February 23, 2017.
Company Profile
This profile covers Omron (Dalian) Co., Ltd. (Plant 1) based in Dalian, China.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 0
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected January 21, 2009. Last inspected February 23, 2017.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate DHR procedures1 inspection
- Lack of or inadequate In-process acceptance procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 23, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1005604 |
| October 20, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 752079 |
| January 21, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 562050 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Promedical Products Co., Ltd.
Jianyi Enterprises
Suzhou 66 Vision Tech Co., Ltd.
Betacera Inc.
Guangzhou Aokewei Electronic Co., Ltd.
Xi'an Friendship Medical Electronics Co., Ltd.
Sunny Medical Device (Shenzhen) Co., Ltd.
Xiantao Lingyang Plastic Co., Ltd
NINGBO SHUN YE MEDICAL COMPANY, LTD.
Roosin Medical Co., Ltd.
Company Information
Name
Omron (Dalian) Co., Ltd. (Plant 1)
FEI Number
3001373226
Address
Economic, No. 3 Songjianglu; Jinzhou, Dalian, China
Country
China
ID: 3501893a-8254-4aa6-baff-2d9a1f6e3d0b