FDA Inspection
Philip A TIbbs MDPhilip A TIbbs MD – FDA Inspection, Aug 13, 2009
Record Details
This FDA Inspection record concerns Philip A TIbbs MD, with an inspection on August 13, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Philip A TIbbs MD
- Inspection Date
- August 13, 2009
- Product Type
- Devices
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ID · 7e140200-14a0-48f5-93d4-ab5f6e1b3a9a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 599721
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
8- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 812.140(a)(3)(ii)Investigator records of relevant observations inadequate
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
- 21 CFR 812.140(a)(1)Investigator correspondence records inadequate
- 21 CFR 812.140(a)(4)Investigator record of protocol deviations inadequate
- 21 CFR 812.140(a)(5)Additional investigator records FDA requires
- 21 CFR 812.140(a)(2)(iii)Investigator records of disposition of devices inadequate
- 21 CFR 812.100No investigator protection - subject rights, safety, welfare
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