FDA 483 - Hospira, Inc., A Pfizer Company - June 08, 2016

This FDA Form 483 details observations from an inspection of Hospira Inc., a Pfizer Company, a human drug/device manufacturer located at 1776 Centennial Dr., McPherson, KS 67460. The inspection occurred from May 16-21, 23-27, and June 8, 2016. Jonathan J. Rushford, Site Head/Vice President Operations, was the individual to whom the report was issued.

The inspection revealed nine observations related to the firm's quality system for drugs and devices:

1. **Inadequate Investigations:** Investigations into discrepancies and batch failures (specifically label defects on ADD-Vantage plastic vials) did not extend to other potentially impacted batches or products, despite a root cause implicating an entire product line and high defect rates found in retention samples. This was a repeat observation from April 3, 2015. 2. **Inadequate Reserve Sample Examination:** Reserve samples were not visually examined at least annually for all types of deterioration, and statistical procedures for sample selection were inadequate, failing to detect pervasive label degradation in the ADD-Vantage line. 3. **Failure to Submit Field Alert:** The firm did not submit an FDA Field Alert within three working days despite receiving complaints and performing retention sample evaluations between April 2015 and June 2015 that showed significant label deterioration across multiple lots and products. 4