# FDA 483 - Hospira Inc. - July 13, 2012

Source: https://www.keypedia.com/records/483/hospira-inc/11f2e46f-2756-4b6e-a8b0-104f23b3f5ac

> FDA 483 for Hospira Inc. on July 13, 2012. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hospira Inc.
- Inspection Date: 2012-07-13
- Office Name: Chicago District Office
- Summary: 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

## Related Documents

- [WARNING_LETTER - 2013-02-07](https://www.keypedia.com/records/warning_letter/hospira-inc/282a1745-3715-4bad-9609-1e348117644b)
- [483 - 2013-02-07](https://www.keypedia.com/records/483/hospira-inc/5b396c70-7515-4fcc-9a94-94fe68927fe0)

## Related Officers

- [Medical Device Specialist](https://www.keypedia.com/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.keypedia.com/companies/hospira-inc/55859dcf-48b7-4e20-8d7f-71f42e389ca8

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669