FDA 483 - Avara Liscate Pharmaceutical Services SPA - May 13, 2014

Hospira S.p.A. in Liscate, Italy, a sterile drug manufacturer, was inspected by the FDA. The inspection revealed significant deficiencies in aseptic processing, including inadequate sterilization validation, environmental monitoring, and cleaning procedures. Additionally, issues with data integrity, laboratory record-keeping, and complaint investigations were noted, indicating a lack of robust quality control systems.