FDA 483 - Hospira Inc. - July 13, 2012

This FDA Form 483 details multiple observations for a medical device manufacturer, focusing on issues with Medical Device Reporting (MDR), complaint handling, corrective and preventive actions (CAPA), supplier management, and documentation.

**Key Violations and Observations:**

* **Incomplete MDR Reporting:** MDR # 2921482-2009-00107, concerning a death involving a PLUM A+ infusion pump, failed to correctly report the patient's death (death box unchecked, no date) and omitted critical details from the complaint log, such as "but it was a concern about the tubing and the pump." * **Delayed Complaint Investigation/CAPA:** Parent Exception Report # 34094 (Plum family infusion pumps, operator error) showed significant delays. A draft investigation report from February 2012 was unapproved by June 2012, and management was unaware of its status. Status reports were missed without justification, and a meeting to determine investigation scope was not scheduled as stated. CAPA status report extensions lacked Quality Unit approval. * **Inadequate Investigation and CAPA Initiation:** An investigation (CAPA ER-DVCMH-001299) identified a design issue in Plum and Symbiq pumps (high-temperature/humidity failure mode) but no CAPA or Engineering Change Project was initiated. * **Insufficient Root Cause Analysis