FDA Inspection
Mark A Klaassen, M.D.Mark A Klaassen, M.D. – FDA Inspection, Sep 28, 2010
Record Details
This FDA Inspection record concerns Mark A Klaassen, M.D., with an inspection on September 28, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Mark A Klaassen, M.D.
- Inspection Date
- September 28, 2010
- Product Type
- Devices
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ID · fcd5c301-f0b7-410e-b255-73dd2221d0f5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 683586
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.100Investigator lack of control of investigational devices
- 21 CFR 58.130(e)Conduct: changes not obscuring original entries
- 21 CFR 812.140(a)(3)(ii)Investigator adverse effect records inadequate
- 21 CFR 812.140(a)(1)Investigator correspondence records inadequate
- 21 CFR 812.110(a)Subject participation prior to study approval
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Other FDA inspections of Mark A Klaassen, M.D.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 18, 2012 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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