- CordenPharma Colorado completed inspections by ANVISA and the U.S. FDA with no observations issued.
- The FDA visit was unannounced, and the site received a No Action Indicated (NAI) rating.
CordenPharma Colorado has completed two regulatory inspections with no observations issued. The site hosted inspectors from the Brazilian National Health Surveillance Agency (ANVISA) between 20 and 24 October, resulting in a clean outcome.
On 10 November, the site underwent an unannounced inspection by the U.S. Food and Drug Administration. The review covered both Boulder, Colorado locations and concluded on 14 November. The FDA inspection resulted in no FDA-483 being issued and received a No Action Indicated rating.
The company said the results reflect the work of its Colorado teams and highlighted its role as a CDMO partner in maintaining quality and compliance across its operations. According to the press release, the organisation aims to continue strengthening its quality systems.
“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.”
CEO and President Dr Michael Quirmbach
