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

An FDA inspection was conducted at Merck Research Laboratories in West Point, PA, from June 1-5, 2009. This comprehensive inspection of a nonclinical laboratory facility identified seven significant observations, documented in an FDA Form 483. Main issues included insufficient documentation of test article suspension handling during dosing for three evaluated studies. The final study reports were deficient, lacking signed and dated contributions from individual scientists. Furthermore, both study protocols and final reports failed to fully identify all automated systems used for data collection, specifically for antemortem and pathology data. A Standard Operating Procedure (SOP SA-4053) for bioanalytical method validation was found to have overly wide acceptance limits for stability assessments, raising concerns about data accuracy. The inspection also noted that email correspondence specific to study activities was not consistently maintained. Lastly, the pathology data system indicated that certain required histopathological examinations of tissues, such as tibias and lymph nodes, were not performed as stipulated for specific study animals. Merck management committed to providing a written response to the Agency addressing these findings.