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

This FDA Form 483 details multiple observations from an inspection, highlighting significant deficiencies in the facility's quality control, manufacturing processes, and adherence to established procedures.

**Facility and Operations:** The inspection covers manufacturing of aseptically produced products including liquid, lyophilized vials, and carpujects. Products mentioned include Daptomycin, Demeclocycline HCl Injection, Retacrit Injection, Vancomycin HCl for Injection, Hydromorphone HCl Injection, Fentanyl Citrate Injection, Morphine Sulfate Injection, Diazepam Injection, Depacon Valproate Sodium Injection, Glatiramer Acetate Injection, NivestymTM, and Heparin. Raw materials, including APIs and excipients, are weighed in a General Processing Area (GPA) Dispensing Room 401 (Suite) Grade D.

**Violations and Observations:**

* **Quality Control Unit Deficiencies:** The quality control unit's responsibilities and procedures are not fully followed, specifically regarding inadequate impact and risk assessments in a Daptomycin contamination investigation (PR ID: 2200959). * **Process Control and Validation Issues:** * The system for washing, rinsing, and sterilizing components for aseptically produced products is inadequately qualified. Issues include unmonitored water dispensing and failure to maintain required temperatures, based on a 1996 qualification (QP2840QP) that has not been reass