FDA Inspection
Kenneth A. Pettine, MDKenneth A. Pettine, MD – FDA Inspection, Jun 28, 2013
Record Details
This FDA Inspection record concerns Kenneth A. Pettine, MD, with an inspection on June 28, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Kenneth A. Pettine, MD
- Inspection Date
- June 28, 2013
- Product Type
- Devices
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ID · 60c0d978-b665-4f28-8abe-86e661fd0010
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 839676
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.140(a)(3)(i)Investigator records of informed consent inadequate
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Other FDA inspections of Kenneth A. Pettine, MD
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 2, 2011 | OAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| March 30, 2009 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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