FDA EIR - Hospira, Inc., A Pfizer Company - August 15, 2018

Hospira Inc., a Pfizer Company, underwent an FDA follow-up cGMP inspection at its McPherson, KS facility from July 23 to August 15, 2018. This comprehensive review, conducted under several compliance programs for sterile human and animal drugs and biological therapeutic products, covered the company's quality, laboratory, facilities, equipment, materials, production, and packaging systems. The inspection revealed eight significant observations, many of which were repeat violations from previous inspections. Key issues included persistently inadequate investigations into discrepancies like mold concerns and equipment failures, deficiencies in change control management, and a failure to submit required Field Alert Reports in a timely manner. The FDA also noted inadequate aseptic procedures, issues with cleaning and controlling equipment in sterile environments, and problematic visual inspection processes. Furthermore, there were concerns regarding the qualification of vendor Certificates of Analysis, insufficient employee training and effectiveness trending, and improperly qualified equipment for particulate control. At the inspection's conclusion, management was reminded of their obligations under the FD&C Act, underscoring the necessity for the company to promptly address these systemic and recurring compliance failures.