FDA 483 - Princeton Biomedical Research, P.A. - May 03, 2000

An FDA inspection initiated on April 11, 2000, at Princeton Biomedical Research, P.A., led by Dr. Jeffrey T. Apter, M.D., resulted in the issuance of an FDA Form 483 on May 3, 2000. This directed, for-cause inspection uncovered significant deficiencies across two clinical trial protocols, indicating non-compliance with regulatory requirements for investigator responsibilities and good clinical practice. Key violations included the screening and diagnosing of research subjects prior to obtaining their informed consent. Diagnoses were frequently made by non-physician raters, with physicians signing off retrospectively or when not physically present at the site. Physical examinations were conducted by a Physician's Assistant without documented sponsor approval. Source documentation was found to be inadequate, characterized by altered, crossed-out, or overwritten dates, lack of currency, and inconsistent presence or documentation of the Principal/Co-Investigator during protocol-required activities. Additionally, enrollment eligibility test scores were improperly changed without supporting documentation, and adverse event reporting lacked consistent causal relationship ratings by a medical doctor, with multiple staff contributing to progress notes, hindering clear accountability. A lack of documentation to confirm screening for prior investigational drug treatment was also noted. These observations highlight a systemic failure to ensure proper conduct and oversight of clinical trials. Princeton Biomedical Research, P.A. is required to address these serious issues to ensure compliance with FDA regulations, safeguard human subjects' rights, and maintain data integrity. Corrective actions, such as updating documentation procedures and ensuring appropriate physician involvement, were discussed during the close-out meeting.