FDA Inspection
Cheryl Roth, PhD RNCheryl Roth, PhD RN – FDA Inspection, Apr 26, 2017
Record Details
This FDA Inspection record concerns Cheryl Roth, PhD RN, with an inspection on April 26, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b31f025e-87f3-4315-8e2c-89f3ba8402a8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1009898
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 812.140(a)(3)(i)Investigator records of informed consent inadequate
- 21 CFR 812.140(a)(3)(iii)Investigator records of exposure to device inadequate
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