FDA 483 - Hospira, Inc. - November 14, 2023

An FDA inspection of Hospira, Inc. in Rocky Mount, NC, revealed significant deficiencies in laboratory controls and product testing. The firm lacked adequate analytical methods to detect unknown impurities in drug products manufactured on shared equipment, including highly potent drugs. Additionally, Hospira failed to perform container closure integrity testing as part of its release criteria, raising concerns about product sterility and quality.