FDA EIR - Princeton Biomedical Research - September 24, 1997

An FDA inspection of Princeton Biomedical Research (PBR), led by Principal Investigator Dr. Jeffrey T. Apter, occurred on September 10-12, 16-18, and 24, 1997. The inspection focused on clinical study Protocol ███████, conducted under the regulatory framework of C.P. 48811. The main issues identified resulted in an FDA-483, indicating several observations.Key violations included significant adverse event reporting failures: a serious adverse event for subject #01109 was reported to the IRB nearly 105 days late, and another adverse event ("severe impotence") was documented in the subject chart but omitted from the sponsor's case report form. Furthermore, five out of twelve reviewed subject records displayed protocol deviations, such as incomplete blood pressure documentation, extended study duration, and missing vital sign records. Two physicians, Dr. R. Pine and Dr. H. Chander, performed study evaluations but were not listed on the required FDA Form 1572 as subinvestigators. Other concerns involved missing or incomplete Informed Consent Forms for several subjects and the retention of original raw data (ECGs) by the sponsor rather than at the site. Initial discrepancies in test article accountability were also noted, though later reconciled.PBR is expected to provide a written response to the FDA-483 observations. Recommended actions for future studies include promptly updating FDA Form 1572 for all participating personnel, ensuring comprehensive and timely adverse event reporting, adhering strictly to protocol requirements, retaining original raw data at the study site, and maintaining complete and accurate Informed Consent Forms and test article accountability records. Dr. Apter and Ms. Soika acknowledged these findings and committed to implementing improvements.