News & Press
CordenPharma is pleased to announce that our CordenPharma Bergamo (IT) Active Pharmaceutical Ingredient (API) manufacturing facility, completed a four day general inspection conducted by the U.S. Food and Drug Administration (FDA) in September 2018. The inspection outcome has now been closed (November 16th) by the FDA and classified with a “VAI” status (Voluntary Action Indicated).
Esua Macniell, Chief Compliance Officer of CordenPharma Group comments, “We are pleased with the outcome and the rapid closure of the FDA Inspection at CordenPharma Bergamo. This is the fourth successful inspection of a CordenPharma manufacturing site in 2018 and reflects our high level of professionalism, authenticity and cGMP regulatory compliance, which fully lives up to the laws and regulations of the United States Authorities.”