483
MSD Ireland (Carlow)MSD Ireland (Carlow) – FDA 483, Nov 22, 2019
Record Details
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.
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ID · f4627655-2699-40e9-86a0-5cf59b277f69
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