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

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

Publication: Warning Letter Bulletin
Publication Date: 01-SEP-06

Format: Online
Delivery: Immediate Online Access

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...

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...failed to obtain informed consent, and failed to ensure...

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