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Barry Eppley, M.D., Riley Hospital for Children, Indianapolis, Aug. 22 (CDRH).

Publication: Warning Letter Bulletin
Publication Date: 01-SEP-06 		Format: Online
Delivery: Immediate Online Access
Full Article Title: Barry Eppley, M.D., Riley Hospital for Children, Indianapolis, Aug. 22 (CDRH).(MEDICAL DEVICES)

Article Excerpt
FDA conducted an investigation at Eppley's site May 18-31, to determine whether activities and procedures related to his participation in the clinical study complied with applicable FDA regulations for medical devices.

Several violations were noted, including that Eppley had consistently failed to obtain informed consent, and failed to ensure...

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