FDA EIR - MERCK RESEARCH LABORATORIES DIV MERCK CO INC - June 05, 2009

An FDA inspection of Merck Research Laboratories in West Point, PA, was conducted from June 1-5, 2009. This comprehensive surveillance and full facility inspection of a nonclinical laboratory fell under the regulatory framework of C.P. 7348.808 (Nonclinical Laboratories), indicating adherence to Good Laboratory Practices (GLPs). The inspection resulted in a seven-item FDA Form 483, detailing significant observations. Key issues included a lack of documentation confirming proper handling of test article suspensions during dosing for three tracked studies. Final study reports were found deficient as they did not include signed and dated reports from individual contributing scientists. Furthermore, both study protocols and final reports failed to adequately identify all automated systems used for data collection, such as specific antemortem and pathology data systems. A crucial Standard Operating Procedure (SOP SA-4053) for bioanalytical method validation was noted to have excessively wide acceptance limits for stability assessments, potentially compromising data accuracy. The firm also did not maintain email correspondence specific to study activities, and pathology records indicated unexamined histopathological samples (tibia and lymph nodes) from certain animals in one study. Merck's management confirmed they would provide a written response to the Agency to address these inspectional observations.