FDA 483 - MSD Ireland (Carlow) - May 28, 2024

During an FDA inspection conducted from May 21-24 and May 27-28, 2024, MSD International GmbH T/A MSD Ireland (Carlow), a pharmaceutical manufacturer, received an FDA Form 483 citing three significant observations. The inspection focused on the company's manufacturing processes, highlighting areas needing improvement to ensure product quality and patient safety.Key issues identified included an inadequate 'first air' operation for adding stoppers into a vial filling line, where the sanitization process was observed to compromise the sterile environment. Furthermore, the firm's smoke study for the vial filling line was deemed insufficient, as it did not include evaluations for stopper introduction into the Grade A filling line prior to decontamination. The third observation concerned the visual inspection process for drug products, which lacked adequate process controls or established alert/action limits for vials rejected due to particles or process interruptions.These observations indicate potential deviations from current Good Manufacturing Practices (GMP) related to maintaining sterile conditions and ensuring robust quality control in manufacturing and inspection processes. MSD Ireland is expected to promptly address these findings by developing and implementing comprehensive corrective and preventive actions to rectify the identified deficiencies and ensure compliance with regulatory standards.