- CARBOGEN AMCIS, part of the Dishman Carbogen Amcis Group, has completed its first U.S. Food and Drug Administration (FDA) Pre-Approval Inspection (PAI) at its Vionnaz facility in Switzerland without the issuance of a Form 483.
- The September 7–11, 2026 inspection covered manufacturing, process validation, analytical methods, equipment qualification, quality systems and other aspects of the product and manufacturing process.
CARBOGEN AMCIS, part of the Dishman Carbogen Amcis Group, has completed its first FDA Pre-Approval Inspection at its Vionnaz facility in Switzerland. The FDA conducted the inspection from September 7 to 11, 2026, as part of the regulatory review of a product manufactured at the site. The inspection concluded without the issuance of a Form 483.
The inspection covered manufacturing and batch documentation, process validation, equipment qualification, analytical method validation, cleaning validation, supplier qualification, change control, deviations, corrective and preventive actions (CAPAs), and training. The company said the inspection focused on key aspects of the product and its manufacturing process.
The Vionnaz facility specializes in the development and small-scale manufacture of highly potent APIs, including warheads and linkers for antibody-drug conjugates. The site includes dedicated process development, production and quality control facilities.
Stephanie Schlienger, V.P. Quality & Compliance at CARBOGEN AMCIS, said, “This first FDA Pre-Approval Inspection is an important milestone for our Vionnaz site. Its successful completion reflects our continued focus on quality and compliance in the development and manufacture of highly potent APIs.”
“Completing the inspection without a Form 483 was a positive outcome for the site. He also thanked the teams involved in preparing for and supporting the inspection.”
Stephan Fritschi, CEO of CARBOGEN AMCIS
