CordenPharma Colorado Completes Two Successful Regulatory Inspections from the FDA & ANVISA with No Observations Received

Between 20–24 October, our CordenPharma Colorado site had the opportunity to host inspectors from the Brazilian National Health Surveillance Agency (ANVISA), which resulted in no observations received.

Additionally, on Monday, 10 November, the site received an unannounced visit from the U.S. Food and Drug Administration (FDA), which included a general inspection of both Boulder, CO locations completed on Friday, 14 November. The FDA inspection did not result in an issuance of an FDA-483 and will be rated No Action Indicated (NAI), with no observations received.

We are proud of these successful results, driven by the professionalism and hard work of our CordenPharma Colorado teams. We value the trust you place in us as your CDMO partner and look forward to further strengthening our operations and quality systems to uphold these high standards moving forward.

CEO & President Dr. Michael Quirmbach commented, “I want to extend my heartfelt thanks to the outstanding efforts of the Colorado teams during the recent FDA and ANVISA inspections. Their dedication, attention to detail, and commitment to quality reflect the strength of our teamwork and played a crucial role in achieving both excellent outcomes.”