FDA 483 - Merck Sharp & Dohme LLC - September 09, 2019

An FDA inspection of Merck Sharp & Dohme Corporation in West Point, PA, revealed numerous deficiencies in their manufacturing and quality control processes for licensed biological products. Key issues included inadequate investigations into out-of-specification results and product quality complaints, recurrent deviations in drug substance production, and insufficient environmental monitoring and equipment control. The firm also demonstrated shortcomings in laboratory controls, record-keeping, and the management of critical biological materials and reserve samples.