FDA EIR - Hospira, Inc., A Pfizer Company - April 03, 2015

An FDA inspection was conducted at Hospira Inc. in Mcpherson, KS, from March 23 to April 3, 2015. This inspection primarily served to follow up on deficiencies identified during a previous assessment, dated April 14-23, 2015, which had resulted in a Voluntary Action Indicated (VAI) classification. The prior inspection cited two main issues under Good Manufacturing Practices: inadequate process validation activities and insufficient information in complaint investigations. Additionally, three verbal observations highlighted the need for improved training in visual inspection for particulates in injectable products, enhanced control over packaging and labeling to prevent the use of outdated materials, and resolution of annual product review deficiencies. During the March-April 2015 inspection, the FDA confirmed that Hospira Inc. had adequately addressed all these previously noted deficiencies. The company was reminded of its responsibilities to comply with the Federal Food, Drug, and Cosmetic Act and committed to providing a written response to the original observations within 15 days.