FDA Inspection
Marzluff, MikeMarzluff, Mike – FDA Inspection, May 13, 2009
Record Details
This FDA Inspection record concerns Marzluff, Mike, with an inspection on May 13, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Marzluff, Mike
- Inspection Date
- May 13, 2009
- Product Type
- Devices
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ID · c2fe4503-b730-495f-ae2b-1126aeceeeca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 583923
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 812.110(d)Inadequate financial disclosure by investigator
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