FDA Inspection
Omron Healthcare Co., Ltd.Omron Healthcare Co., Ltd. – FDA Inspection, Sep 29, 2011
Record Details
This FDA Inspection record concerns Omron Healthcare Co., Ltd., with an inspection on September 29, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Omron Healthcare Co., Ltd.
- Inspection Date
- September 29, 2011
- Product Type
- Devices
View Company Profile
ID · 718b5a3b-bfc5-4386-9560-9f9b891a08a5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 750675
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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Other FDA inspections of Omron Healthcare Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 27, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 29, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Omron Healthcare Co., Ltd.
- FDA Inspection 1050362 - 2018-02-27
- FDA Inspection 932436 - 2015-05-29
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