FDA 483 - Corden Pharma S.p.A. - October 18, 2017

Corden Pharma S.p.A. in Caponago, Italy, received a Form 483 following an inspection, citing six observations related to drug manufacturing. The observations primarily concern deficiencies in environmental monitoring, equipment qualification records, adherence to established specifications, and the lack of defined time limits and critical process parameters for drug production. Additionally, issues were noted with procedures to prevent microbiological contamination and inadequate documentation of line clearances for drug product closures.