- CARBOGEN AMCIS completes FDA inspections with no critical findings.
- Inspections at Neuland and Aarau sites conclude with No Actions Indicated (NAIs).
CARBOGEN AMCIS, a Switzerland-based pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, has successfully completed U.S. Food and Drug Administration (FDA) inspections at its Neuland and Aarau sites. The inspections, conducted in June 2024, concluded with no Form 483 observations or significant critical findings.
The FDA carried out routine inspections over five days at the Neuland site from June 17-21, 2024, and over three days at the Aarau site from June 24-26, 2024. Both inspections concluded with No Actions Indicated (NAIs), affirming the company’s adherence to high-quality standards.
Pascal Villemagne, CEO of CARBOGEN AMCIS, commented, “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.”
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.”
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