FDA Inspection
Electromedical Products International, Inc.Electromedical Products International, Inc. – FDA Inspection, Dec 18, 2009
Record Details
This FDA Inspection record concerns Electromedical Products International, Inc., with an inspection on December 18, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 18, 2009
- Product Type
- Devices
View Company Profile
ID · a22b6f7c-868b-4902-92cb-cf325c7d3fd5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 636051
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.198(a)(1)Uniform and timely processing
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(f)Records accessibility
- 21 CFR 820.20(c)Management review accomplishment
- 21 CFR 820.90(a)Specific non-conforming product procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(e)(5)Nature and details of complaint
- 21 CFR 820.181(c)DMR QA procedures and specifications
- 21 CFR 820.181DMR - not or inadequately maintained
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Other FDA inspections of Electromedical Products International, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 2, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 29, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 1, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Electromedical Products International, Inc.
- FDA Inspection 1039669 - 2018-02-02
- FDA Inspection 863799 - 2014-01-29
- FDA Inspection 816802 - 2013-02-01
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