Regulatory Inspections & Certifications

2019 Regulatory Inspections & Certifications

February 07, 2019 2019: Successful FDA Inspections & Certifications for CordenPharma in 2019.

July 23, 2019

CordenPharma Plankstadt Awarded Corporate Social Responsibility Silver Medal by EcoVadis

CordenPharma Plankstadt (DE) are pleased to announce the award of the Silver medal by the independent agency EcoVadis in June 2019 as a recognition of their CSR (Corporate Social Responsibility) Rating. The rating is a testament to CordenPharma’s dedication to sustainability with regards to environmental, labor & human rights, ethics and sustainable procurement. CordenPharma received an overall score of 87th percentile.

Dr. Riku Rautsola, CEO of CordenPharma & Acting Managing Director of CordenPharma Plankstadt commented, “We are excited to receive The EcoVadis silver rating for our initiatives in Plankstadt, as Corporate Social Responsibility plays an important role in the strategy of our growing business. As a CDMO, we are consistently seeking ways to make a positive impact on social, economic & environmental factors which affect our employees, their communities and the world at large.”

February 7, 2019

CordenPharma Colorado Completes Successful FDA Inspection

CordenPharma is pleased to announce that on February 6, 2019 our CordenPharma Colorado (USA) manufacturing facility completed a 6 day surveillance Inspection conducted by the US FDA. All Quality Systems were evaluated. The facility received a successful response with one FDA 483 observation reported.

Brian McCudden, Managing Director of CordenPharma Colorado comments, “We are pleased with the outcome of the FDA Inspection, as it reflects our high level of compliance with cGMP regulations & guidelines and the commitment, talent and professionalism of our staff.”