FDA EIR - Merck Sharp & Dohme LLC - September 20, 2019

An FDA inspection was conducted at Merck Sharp & Dohme Corp.'s West Point, PA facility from September 9-20, 2019. As a large licensed biological (vaccine) manufacturer operating under U.S. License No. 002, the inspection followed Compliance Program C.P 7348.858 for Biological Products (Level I, Vaccines), covering Quality, Production, Facilities, and Laboratory Systems. Key deficiencies, resulting in a fifteen-item Form FDA-483, included failures to thoroughly investigate unexplained discrepancies or out-of-specification (OOS) results (e.g., PedvaxHIB), with investigation records lacking complete assessments for adverse events or medical impact. Drug substance bulk deficiencies were not adequately investigated, and Product Quality Complaints and Adverse Event Quality Investigation Reports lacked comprehensive findings. The inspection also identified issues with facility controls, such as inadequate monitoring of temperature-controlled devices, unorganized/unsecured freezers, and deficiencies in environmental monitoring within aseptic processing areas, where the efficacy of disinfectants was not established. Laboratory controls were found lacking scientifically sound specifications, with incomplete data in records and insufficient data review. Additionally, procedures for managing reference standards were inadequate, and qualification validation for walk-in cold rooms used for reserve samples was not performed. The reserve sample program itself was deemed insufficient, with an inadequate sampling plan for annual visual inspections of retained product. Corrective actions are required for these observations.