FDA Inspection
Omron Healthcare, Inc.Omron Healthcare, Inc. – FDA Inspection, May 13, 2011
Record Details
This FDA Inspection record concerns Omron Healthcare, Inc., with an inspection on May 13, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Omron Healthcare, Inc.
- Inspection Date
- May 13, 2011
- Product Type
- Devices
View Company Profile
ID · 5da7bfcb-52ae-49e4-9e29-15849db24a78
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 731708
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 803.40(a)Report of death, injury
- 21 CFR 803.40(b)Report of malfunction likely to cause death or injury
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Other FDA inspections of Omron Healthcare, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 22, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Omron Healthcare, Inc.
- FDA Inspection 772787 - 2012-03-22
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