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

A comprehensive FDA inspection of Merck Research Laboratories in West Point, PA, was conducted from August 16-20, 2010. This surveillance and full facility inspection of a nonclinical laboratory was performed under the regulatory framework of Good Laboratory Practices (GLP) and the Bioequivalence Investigations Branch, specifically covered under C.P. 7348.808 for Nonclinical Laboratories. The inspection primarily aimed to assess corrective actions following a June 2009 inspection that resulted in an FDA Form 483. Previous deficiencies included incomplete documentation for accurate dosing, final reports lacking essential elements (such as signed contributing scientist reports and specified methods), inadequate protocol descriptions and adherence to histopathological evaluations, unarchived study-related correspondence, and insufficient procedures for bioanalytical method stability assessments. During the 2010 inspection, FDA investigators reviewed two completed toxicity studies, Standard Operating Procedures, facility operations, and personnel training. They observed that Merck Research Laboratories had implemented significant corrections to address all deficiencies cited in the previous inspection. Consequently, at the conclusion of the inspection, no new deficiencies were observed, and no FDA Form 483, Inspectional Observations, was issued. Discussions did include the firm's ongoing efforts to formalize the archiving of study-related email communications and ensure consistent inclusion of pathology peer review documentation in final reports, although these were not cited as new violations.