FDA 483 - Hospira, Inc. - November 21, 2019

An FDA inspection of Hospira a Pfizer Company in Rocky Mount, NC, a sterile injectable manufacturer, revealed significant deficiencies in laboratory controls and quality system investigations. Observations included inadequate sampling plans for bacterial endotoxin testing, failure to thoroughly review bioburden and environmental monitoring excursions, and incomplete investigation records lacking conclusions and follow-up actions. These issues suggest a lack of robust quality oversight in critical manufacturing and quality control processes.