Successful FDA Inspection for CordenPharma Switzerland

November 2, 2018
News > CordenPharma Switzerland Receives Successful FDA Inspection

News > CordenPharma Switzerland Receives Successful FDA Inspection

CordenPharma is pleased to announce that on November 2, 2018 the US Food and Drug Administration (FDA) completed a 5-day inspection of our CordenPharma Switzerland manufacturing facility. The inspection focused on product-specific processes and documentation in the cGMP compliant production of APIs and various multi-customer phospholipids used as excipients, as well as a general review of our site-wide quality system.

The facility received a successful response with no FDA Form 483 observations reported. The inspector expressly praised the open, supportive and positive behavior of the audited employees, along with their high level of professionalism and competence. It was also acknowledged that a tremendous amount of high-quality preparatory work was done.

Juerg Burger, Managing Director of CordenPharma Switzerland comments, “We are proud with the outstanding result of the recent FDA inspection, which directly reflects the tireless individual commitment of every single employee in their daily work at CordenPharma Switzerland.”