FDA EIR - John Joseph Hewett, M.D. - May 15, 2012

An FDA inspection of John Joseph Hewett, M.D., in Newport Beach, CA, was conducted from March 23, 2012, to May 15, 2012. This unannounced, for-cause inspection evaluated the clinical investigator's compliance with regulatory standards, specifically under Compliance Program 7348.811, concerning two clinical trials. The inspection resulted in the issuance of a 3-item FDA-483, detailing significant observations. Key issues included the improper documentation of informed consent, as the consent forms used for study subjects had not been approved by the Institutional Review Board (IRB), indicating a deviation from 21 CFR Part 50 requirements. Additionally, the investigation was not conducted according to the signed agreement, and there was an absence of comprehensive accountability records for medical devices (receipt, use, and disposition) used in one of the protocols from July 26 to December 31, 2011. Dr. Hewett indicated he would submit a written response to these findings within 15 days. The FDA also noted that further regulatory actions, potentially including a Warning Letter or disqualification, could be pursued.