Regulatory Inspections & Certifications

2019 Regulatory Inspections & Certifications

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

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.”