Company
JapanOmron Healthcare Co., Ltd., Muko, Japan – FDA Inspections
Inspection records and compliance data for Omron Healthcare Co., Ltd. in Muko. 3 FDA inspections on record, last inspected February 27, 2018.
Company Profile
This profile covers Omron Healthcare Co., Ltd. based in Muko, Japan.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected September 29, 2011. Last inspected February 27, 2018.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of System for Determining MDR Events1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 27, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1050362 |
| May 29, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 932436 |
| September 29, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 750675 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Omron Healthcare Co., Ltd.
FEI Number
3004072282
Address
53, Terado-Cho, Muko, Japan
Country
Japan
ID: 7a6fa0cf-d6d0-4080-8f6a-9212bdc7d3b9