FDA 483 - NWL Netherlands Services B.V. - October 18, 2024

NWL Netherlands Services B.V., a drug manufacturer in Hillegom, was cited for significant deficiencies across its quality control unit, computer system controls, and laboratory operations. The inspection revealed failures in record-keeping, change control, stability studies, OOS investigations, data integrity, component identity testing, and water system monitoring. These issues indicate a systemic lack of adherence to good manufacturing practices, posing risks to drug product quality and purity.