MSD Ireland (Carlow)November 22, 2019

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

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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.

Company: MSD Ireland (Carlow)
Inspection Date: November 22, 2019
Product Type: Biologics
Office: International Compliance Team
Person: Mihaly S. Ligmond (CSO)

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ID · f4627655-2699-40e9-86a0-5cf59b277f69