FDA WARNING_LETTER - Adams, Mark M.D. - October 18, 2007

An FDA inspection conducted from October 11-18, 2007, at Dr. Mark Adams' clinical site in Saginaw, MI, for the "PRESTIGE LP Cervical Disc System" study (IDE [redacted]), revealed serious violations of federal regulations. The inspection aimed to ensure scientific validity of data and protection of human subjects. Deficiencies included failures to ensure and appropriately document informed consent, as exemplified by a photocopied subject signature. Dr. Adams also failed to report the use of a device without informed consent to the sponsor and IRB within five working days. Further violations involved not conducting the investigation in accordance with the signed agreement, investigational plan, and applicable FDA regulations, such as enrolling a subject with pending spinal litigation, incomplete preoperative tests for multiple subjects, delayed follow-up visits, and unsubmitted case report forms. The site also failed to maintain accurate, complete, and current records of subject case histories, with missing source documents. Additionally, a discrepancy in device accountability records was noted. These issues violate 21 CFR Parts 812 and 50, and Section 520(g) of the Act. Dr. Adams is required to provide a written response within fifteen working days, detailing corrective actions and projected completion dates. Failure to comply could result in further regulatory action, including disqualification proceedings.