FDA 483 - Corden Pharma S.p.A. - July 15, 2016

During an inspection from July 7-15, 2016, the FDA observed significant deficiencies at Corden Pharma S.p.A. in Caponago, Italy, a drug manufacturer. The findings primarily concern inadequate laboratory controls, including unvalidated test methods and incomplete records, as well as issues with facility maintenance, personnel gowning, and quality system investigations into product complaints. These observations indicate a lack of adherence to good manufacturing practices.