FDA Inspection
Omron Healthcare Co., LtdOmron Healthcare Co., Ltd – FDA Inspection, Oct 6, 2011
Record Details
This FDA Inspection record concerns Omron Healthcare Co., Ltd, with an inspection on October 6, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Omron Healthcare Co., Ltd
- Inspection Date
- October 6, 2011
- Product Type
- Devices
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ID · fc16695b-f89a-443f-886d-480373d9a3b9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 750677
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.198(a)Complaints
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.198(b)Rationale documented for no investigation
- 21 CFR 820.250(b)Sampling plans
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Other FDA inspections of Omron Healthcare Co., Ltd
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 2, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 26, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Omron Healthcare Co., Ltd
- FDA Inspection 1050806 - 2018-03-02
- FDA Inspection 932431 - 2015-05-26
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