FDA Inspection
Stachniak, Joseph B., M. D.Stachniak, Joseph B., M. D. – FDA Inspection, Apr 12, 2010
Record Details
This FDA Inspection record concerns Stachniak, Joseph B., M. D., with an inspection on April 12, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Stachniak, Joseph B., M. D.
- Inspection Date
- April 12, 2010
- Product Type
- Devices
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ID · 149e5a1c-e497-412d-9cf6-f8213c77d6f4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 658296
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.140(a)(3)(ii)Investigator adverse effect records inadequate
- 21 CFR 812.140(a)(2)(i)Investigator device accountability inadequate
- 21 CFR 812.140(a)(4)Investigator record of protocol deviations inadequate
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