FDA 483 - Corden Pharma Bergamo SPA - June 17, 2016

Farchemia S.r.l., an API manufacturer in Treviglio, Italy, was cited for significant quality control deficiencies during an FDA inspection. Observations included failure to test re-used API raw materials, lack of bulk hold studies for stored API, inadequate controls over laboratory computer systems, and deficient equipment cleaning validation. These issues indicate a lack of robust quality systems and data integrity.