USFDA successfully inspects Carbogen Amcis’s manufacturing sites in Neuland and Aarau

The inspections concluded with no Form 483 observations or significant critical findings

Switzerland-based Carbogen Amcis, a leading pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, has announced the successful completion of U.S. Food and Drug Administration (FDA) inspections at its Neuland and Aarau sites.

The FDA conducted routine inspections over five days in Neuland from June 17-21, 2024, and three days in Aarau from June 24-26, 2024. The inspections concluded with no Form 483 observations or significant critical findings, affirming that No Actions Indicated (NAIs) were identified.

“The successful inspections at our Aarau and Neuland sites highlight Carbogen Amcis’s consistent track record of high-quality development and manufacturing. This achievement reinforces our commitment to delivering the superior quality our customers expect,” said Pascal Villemagne, CEO of Carbogen Amcis. “Our Quality Team collaborates closely with every Carbogen Amcis facility to uphold a robust and reliable quality policy across the company.”

“I am delighted about these positive reports from the FDA,” said Arpit Vyas, Global Managing Director of the Dishman Group. “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.”