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

An FDA inspection of Merck Research Laboratories in West Point, PA, was conducted from August 16-20, 2010. This comprehensive surveillance inspection of a nonclinical laboratory operated under Good Laboratory Practices (GLP) regulatory framework. Its primary objective was to assess the company's compliance and review corrective actions taken in response to a June 2009 inspection that resulted in an FDA Form 483 with several observations. Previous deficiencies included incomplete dosing documentation, final reports lacking essential elements such as signed contributing scientist reports and detailed methods, unarchived study correspondence, and inadequate bioanalytical method stability assessment procedures. During the 2010 inspection, FDA investigators found that Merck had implemented substantial corrections. New standard operating procedures (SOPs) were established and followed for dosing documentation, contributing scientist reports, and bioanalytical method validation. The inclusion of automated systems in study protocols and reports was also addressed. While a company-wide policy still prevented direct email archiving, Merck implemented a workaround using correspondence records and was actively working on revising their policy. Pathologist refresher training was conducted to prevent recurrence of histopathology errors. At the conclusion of the inspection, no new deficiencies were observed, and no FDA Form 483 was issued, indicating successful remediation of prior issues and demonstrating compliance with GLP regulations.