FDA EIR - Frederick C Whittier J MD - September 12, 2007

An FDA inspection of Frederick C. Whittier Jr. M.D. in Canton, OH, conducted from August 22 to September 12, 2007, identified significant non-compliance with regulatory requirements for clinical investigations. This "for cause" inspection, initiated after the sponsor discontinued several studies due to insufficient oversight, found multiple violations primarily under 21 CFR 312.60 and 21 CFR 312.62(b).

Key findings included the enrollment of ineligible subjects and administration of unapproved treatments in a rheumatoid arthritis study. Recordkeeping deficiencies were prevalent, with copies maintained instead of original clinical assessment data and drug preparation logs, and unauthorized post-hoc changes made to critical data such as joint counts. Furthermore, a new sample preparation record was created, replacing a damaged original, and progress notes were falsely attributed to staff not present. In a diabetes study, a subject continued receiving the investigational drug for two weeks despite elevated liver enzymes, due to a testing error. A critical lapse in human subject protection was noted, where a subject's consent form was signed by a spouse without documented legal authority.

An Inspectional Observations form (FDA 483) was issued to Dr. Whittier detailing these issues. While the sponsor had already halted the studies at this site, the FDA's findings confirmed the serious nature of the deficiencies, indicating a failure to adhere to the investigational plan, maintain accurate records, and ensure proper informed consent. Dr. Whittier indicated he did not plan to submit a formal written response.