FDA Inspection
Robert J. Hye, M.d.Robert J. Hye, M.d. – FDA Inspection, Jan 4, 2010
Record Details
This FDA Inspection record concerns Robert J. Hye, M.d., with an inspection on January 4, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Robert J. Hye, M.d.
- Inspection Date
- January 4, 2010
- Product Type
- Devices
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ID · 2eeb4938-98da-4da0-ae3f-c9613bc4e764
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 635256
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
- 21 CFR 812.140(a)(1)Investigator correspondence records inadequate
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