FDA Inspection
Michael J. Pelekanos, MDMichael J. Pelekanos, MD – FDA Inspection, Nov 28, 2017
Record Details
This FDA Inspection record concerns Michael J. Pelekanos, MD, with an inspection on November 28, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1035273
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 50.20Consent not obtained, exceptions do not apply
- 21 CFR 812.140(a)(3)(i)Investigator records of informed consent inadequate
- 21 CFR 812.110(a)Subject participation prior to study approval
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