FDA 483 - Avara Liscate Pharmaceutical Services SPA - December 06, 2022

An FDA inspection of Avara Liscate Pharmaceutical Services S.r.l. in Liscate, Italy, a contract drug manufacturer, revealed significant deficiencies in quality control and record-keeping. The firm failed to adequately investigate product complaints, out-of-specification deviations, and ensure the effectiveness of corrective actions. Additionally, the facility lacked proper microbiological control for equipment and maintained deficient batch production records.