FDA 483 - Corden Pharma Bergamo SPA

Corden Pharma Bergamo S.p.A., an API manufacturer in Treviglio, Italy, was cited for multiple deficiencies during an FDA inspection from September 24-27, 2018. Observations included inadequate out-of-specification investigations, lack of corrective and preventative actions for recurring complaints, and insufficient laboratory controls. The firm also lacked proper sanitization frequencies for water systems and contemporaneous batch documentation.