FDA 483 - MSD International GmbH (Singapore Branch) - September 03, 2021

An FDA inspection of MSD International GmbH Singapore Branch, a sterile drug product manufacturer, was conducted from August 25 to September 3, 2021. The inspection resulted in several Form FDA 483 observations, indicating deviations from Good Manufacturing Practices.

Key violations included significant failures in preventing microbiological contamination, such as improper aseptic techniques during filling line setup, operators touching product-contact surfaces with unsterile tools, and inadequate glove monitoring procedures. The firm also lacked assurance that its manufacturing process consistently produced drug products within established control limits, evidenced by batches not meeting validated parameters and unresolved equipment malfunctions. Written procedures for visual inspection were deemed inadequate, as they did not mandate investigation for unknown foreign matter.

Additionally, deficiencies were noted in verifying the reliability of container and closure supplier Certificates of Analysis, particularly regarding sterility, and suppliers were inadequately classified by risk. Lastly, manufacturing areas and equipment exhibited design and maintenance issues, including insufficient access controls for an outdoor storage tank, lack of hot water in a handwash area, and a breach exposing a classified area to an unclassified space. MSD International GmbH is expected to develop and implement corrective actions to address these findings.