Carbogen Amcis Concludes FDA Inspections at Two Manufacturing Sites

CARBOGEN AMCIS, a top pharmaceutical process development and API manufacturing company in Switzerland, has passed FDA inspections at its Neuland and Aarau locations. The FDA performed standard inspections in Neuland for five days from June 17-21, 2024, and in Aarau for three days from June 24-26, 2024. 

The inspections ended without any Form 483 observations or important critical findings, confirming the identification of No Actions Indicated (NAIs).

“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.”

ARBOGEN AMCIS is a part of the Dishman Carbogen Amcis Group. They offer services for drug development and commercialization to pharmaceutical and biopharmaceutical industries, throughout all phases of drug development.