FDA Inspection
Electromedical Products International, Inc.Electromedical Products International, Inc. – FDA Inspection, Feb 2, 2018
Record Details
This FDA Inspection record concerns Electromedical Products International, Inc., with an inspection on February 2, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 2, 2018
- Product Type
- Devices
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ID · fcfd53c2-c923-4caa-866d-7d6be0c8a9ab
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1039669
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.50(b)Approval, inadequate purchasing data
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Other FDA inspections of Electromedical Products International, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 29, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 1, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 18, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Electromedical Products International, Inc.
- FDA Inspection 863799 - 2014-01-29
- FDA Inspection 816802 - 2013-02-01
- FDA Inspection 636051 - 2009-12-18
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