FDA EIR - Hospira Inc. - July 14, 2016

An FDA inspection of Hospira Inc., a Pfizer Company, took place from July 12-14, 2016, at its Lake Forest, IL facility. This was a follow-up inspection under Compliance Program 7382.845 for medical device manufacturers, specifically addressing Hospira's Class II infusion pumps and accessories, regulated under 21 CFR 880.5725. The inspection focused on evaluating corrective actions to previous Form FDA 483 observations and a 2013 Warning Letter.

Previous violations from a 2015 inspection included inadequately established procedures for design validation (specifically, flawed battery reliability testing due to incorrect statistical assumptions), insufficient translation of device design into production specifications (e.g., battery storage temperature and type references), and deficiencies in design change procedures (modifying battery acceptance criteria without sufficient impact testing). Procedures for Corrective and Preventive Actions (CAPA) were also found inadequate, failing to properly investigate non-conforming products or ensure effectiveness checks.

While no new Form FDA 483 observations were issued during the 2016 inspection, two key discussion items were noted. Management’s responses to prior design control observations lacked organization and proper CAPA documentation for effectiveness verification. Additionally, actions taken to correct product non-conformances were not consistently integrated into the formal CAPA system.

In response, Hospira management initiated two new CAPAs (PR ID: 269643 and PR ID: 269653). These actions aim to consolidate past corrective efforts, retrospectively review design assessments, update reliability procedures, and formally investigate and address the non-conformance system deficiencies, with action plans expected within 14 days. Most prior 483 observations were verified corrected, though an ongoing effectiveness check for design transfer of storage conditions remained.