FDA 483 - Hospira Inc. - February 07, 2013

This FDA Form 483 details multiple significant violations for a medical device manufacturer, Hospira, concerning their quality system and manufacturing processes.

**Facility and Operation Details:** The inspection covers various product families including Plum, Gemstar, PCA, Symbiq, and APM infusion pumps. The inspection involved review of Medical Device Reports (MDRs), complaints, CAPAs, design control documents, risk assessments, and supplier audits.

**Violations and Observations:**

* **MDR Reporting Deficiencies:** Several MDRs (e.g., #2921482-2011-00074, #9615050-2011-00233) failed to indicate "death" as an outcome in Block B, despite this information being known through complaints. An additional 20 MDRs (12/2008-12/2011) required follow-up reports to check the "Death" box. * **Inadequate Complaint Handling:** Complaints representing MDR-reportable events were not promptly reviewed, evaluated, or investigated. For instance, Complaint #781360 (Plum A+ device, E403 error, life-threatening injury, MDR #2291432-2011-00016) had an inadequate investigation, failing to identify that E403