FDA 483 - Cambrex Profarmaco Milano Srl - May 15, 2017

Cambrex Profarmaco Milano S.r.l., an API manufacturer in Paullo, Milano, Italy, was cited for multiple deficiencies during an FDA inspection. Key issues include inadequate investigations into discrepancies and out-of-specification results, poor laboratory controls for reference standards and testing, and insufficient computer system controls. Other concerns involved facility maintenance, lack of stability testing, deficient cleaning procedures, and inadequate component testing.