FDA 483 - MSD Ireland (Carlow) - November 22, 2019

MSD International GmbH, T/A MSD Ireland (Carlow) was cited for significant deficiencies in its manufacturing operations. The inspection revealed a failure to thoroughly review unexplained discrepancies, including an out-of-specification result for Pneumovax 23 and incomplete investigations into reported adverse events. Additionally, the firm lacked adequate laboratory controls, specifically regarding sampling plans and established hold times for endotoxin testing.