FDA Inspection
Stefan Rath, MDStefan Rath, MD – FDA Inspection, Mar 17, 2017
Record Details
This FDA Inspection record concerns Stefan Rath, MD, with an inspection on March 17, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Cara M. Minelli (Issuing Officer)
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ID · daa82dde-966f-4c4e-b3c1-774fcc3804a7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1005489
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 812.100Investigator 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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