483
MSD Ireland (Carlow)FDA 483 - MSD Ireland (Carlow) - June 07, 2022
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An FDA inspection of MSD International GmbH T/A MSD Ireland in Carlow, Ireland, a drug/biologic establishment, revealed two significant observations. The firm was cited for deficiencies in environmental monitoring systems within aseptic processing areas and for not establishing adequate control procedures to monitor manufacturing processes that cause variability in drug product characteristics.
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ID · 06a78232-49b5-4d3f-b580-0ec8e67aa6c0