CARBOGEN AMCIS Neuland facility.
CARBOGEN AMCIS has announced that two of its manufacturing sites in Switzerland have passed inspections completed by the U.S. Food and Drug Administration (FDA). The sites in Neuland and Aarau passed with flying colours with no Form 483 observations or significant critical findings, ensuring No Actions Indicated (NAIs) were identified.
Both inspections occurred in June, with Neuland receiving a five-day inspection (17-21 of June 2024) and Aarau a three-day inspection (24-26 of June 2024). The former facility specialises in drug development and small to medium-scale cGMP manufacturing. In contrast, the Aarau site focuses on drug substance development and small to medium-scale cGMP manufacturing.
Pascal Villemagne, CEO of CARBOGEN AMCIS, said, “The successful inspections at our Aarau and Neuland sites highlight CARBOGEN AMCIS’ consistent track record of high-quality development and manufacturing. This achievement reinforces our commitment to delivering the superior quality our customers expect. Our Quality Team collaborates closely with every CARBOGEN AMCIS facility to uphold a robust and reliable quality policy across the company.”
Arpit Vyas, Global Managing Director of the Dishman Group, added, “I am delighted about these positive reports from the FDA. This accomplishment reflects years of dedication and hard work by our team, maintaining the highest standards of quality and building on our extensive record of successful regulatory audits and inspections.”