FDA 483 - Hospira, Inc. - August 04, 2011

Hospira, Inc. in Rocky Mount, NC, a sterile pharmaceutical manufacturer, was cited for significant deficiencies in its quality control and laboratory operations. The inspection revealed a failure to thoroughly investigate out-of-specification results and batch failures, leading to the release of non-conforming product lots. Additionally, the firm lacked scientifically sound test procedures, including inadequate method transfers and verifications for various drug products.