FDA EIR - MERCK RESEARCH LABORATORIES DIV MERCK CO INC - August 20, 2010

A comprehensive surveillance inspection of Merck Research Laboratories in West Point, PA, was conducted by the FDA from August 16-20, 2010. This nonclinical laboratory inspection, governed by Good Laboratory Practices (GLP) and Bioequivalence Investigations guidelines (C.P. 7348.808), served as a follow-up to a previous inspection on June 5, 2009. The prior inspection identified several regulatory issues, including incomplete documentation for accurate dosing, final reports lacking required elements (e.g., signed contributing scientist reports, study methods), protocols not fully describing study conduct, a protocol deviation in histopathological evaluation, inadequate bioanalytical method stability assessments, and a failure to archive study-related correspondence. During the 2010 inspection, FDA investigators reviewed Standard Operating Procedures and two completed toxicology studies. The inspection confirmed that Merck had implemented significant corrective actions in response to the previous observations, updating procedures for dosing documentation, report completeness, bioanalytical validation, and communication archiving. As a result, no new deficiencies were observed, and no FDA Form 483 Inspectional Observations were issued at the conclusion of this inspection. An ongoing discussion involved refining the company's internal policy on archiving study-related email correspondence.