FDA Inspection
Kenneth A. Pettine, MDKenneth A. Pettine, MD – FDA Inspection, Mar 30, 2009
Record Details
This FDA Inspection record concerns Kenneth A. Pettine, MD, with an inspection on March 30, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Kenneth A. Pettine, MD
- Inspection Date
- March 30, 2009
- Product Type
- Devices
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ID · ac68de45-5836-4fa6-a880-58f1700f88ef
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 581731
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 812.150(a)(1)Investigator report of unanticipated adverse effects
- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.100Investigator lack of informed consent
- 21 CFR 812.140(a)(3)(ii)Investigator records of relevant observations inadequate
- 21 CFR 812.140(a)(2)(i)Investigator device accountability inadequate
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Other FDA inspections of Kenneth A. Pettine, MD
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2013 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 2, 2011 | OAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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