FDA WARNING_LETTER - Hospira, Inc. - February 23, 2010

This FDA Warning Letter (10-ATL-12) was issued to Hospira, Inc. following inspections of their pharmaceutical and device manufacturing facilities in Rocky Mount and Clayton, North Carolina, from January 12 - February 23, 2010. The inspections revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211) and Quality System (QS) regulations for medical devices (21 CFR Part 820), rendering their drug products and devices adulterated.

At the Clayton facility, violations included inadequate written procedures for production and process controls, specifically failing to prevent objectionable particulate contamination (primarily stainless steel) in Liposyn, Propofol, and Cleviprex emulsion products. This was a persistent issue, leading to multiple recalls and delayed detection of contamination in expired lots. The Quality Control Unit (QCU) failed to adequately design, control, and monitor manufacturing processes, implement effective corrective actions, and timely complete investigations and Field Alert Reports. Investigations into batch failures were inadequate, failing to identify root causes or extend to other affected lots. The firm also lacked acceptance criteria for retain sample inspections and scientifically sound sampling plans for sub-visible particulates. These were repeat observations from an April 2009 inspection.

At the Rocky Mount facility, the firm lacked adequate written procedures for production and process controls, specifically failing to adequately validate mixing processes for multiple products