FDA Inspection
Ohio Medical CorporationOhio Medical Corporation – FDA Inspection, May 19, 2009
Record Details
This FDA Inspection record concerns Ohio Medical Corporation, with an inspection on May 19, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ohio Medical Corporation
- Inspection Date
- May 19, 2009
- Product Type
- Devices
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ID · a2d413da-cf55-4bab-9d6a-f88368fb709a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 583433
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.80(e)Documentation
- 21 CFR 820.198(a)General
- 21 CFR 820.198(a)(1)Uniform and timely processing
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.184DHR content
- 21 CFR 820.90(a)Nonconforming product evaluation/investigation
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Other FDA inspections of Ohio Medical Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 26, 2024 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 29, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 21, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 9, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 14, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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