FDA Inspection
Ohio Medical CorporationOhio Medical Corporation – FDA Inspection, Nov 26, 2024
Record Details
This FDA Inspection record concerns Ohio Medical Corporation, with an inspection on November 26, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 1b76bb73-0948-4e23-b7c0-bfb4e5ee00fb
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1250929
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
13- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 806.10(b)Time to report - 10 days
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
Showing 10 of 13 citations.
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Other FDA inspections of Ohio Medical Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| May 19, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ohio Medical Corporation
- FDA Inspection 920811 - 2015-12-29
- FDA Inspection 814785 - 2012-12-21
- FDA Inspection 730544 - 2011-06-09
- FDA Inspection 668559 - 2010-06-14
- FDA Inspection 583433 - 2009-05-19
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