483
MSD Ireland (Carlow)FDA 483 - MSD Ireland (Carlow)
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Record Details
MSD International GmbH T/A MSD Ireland (Carlow) received three observations during an FDA inspection. The observations highlight deficiencies in aseptic processing controls, specifically regarding first air operations and smoke studies for a vial filling line. Additionally, the firm's visual inspection process for drug product was found to lack adequate process controls for rejected vials.
- Company
- MSD Ireland (Carlow)
- Product Type
- Drugs
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ID · 6f61a3fb-85c7-4632-9294-d490629ec873