FDA 483 - Hospira, Inc., A Pfizer Company - January 17, 2020

The FDA Form 483 details multiple observations from an inspection, highlighting significant deficiencies in quality control, manufacturing processes, and aseptic practices.

**Observation 1** notes the Quality Control Unit's failure to fully follow responsibilities and procedures, specifically regarding inadequate impact and risk assessments in a Daptomycin contamination investigation (PR ID: 2200959).

**Observation 2** identifies a lack of control procedures to monitor and validate manufacturing processes. The system for washing, rinsing, and sterilizing components for aseptically produced products (liquid, lyophilized vials, carpujects) is not adequately qualified, lacking assurance of proper dispensing of washing agents.

**Observation 3** points to inadequate exhaust or contaminant control systems in production areas. The air handling unit design in the General Processing Area (GPA) Dispensing Room 401 allows air to cascade between rooms due to maintained pressure differentials, potentially contaminating raw materials (APIs and excipients) used for products like Demerol HCl, Retacrit, Vancomycin HCl, Hydromorphone HCl, Fentanyl Citrate, and Morphine Sulfate.

**Observation 5** cites a failure to thoroughly review unexplained discrepancies and batch failures. This includes the inadequate corrective actions for mold recoveries in aseptic Grade A and B zones, leading to the release of Depacon Valproate Sodium Injection, Lot 83170OD, without scientific justification for mitigation through sterilization. Additionally,