FDA 483 - Hospira, Inc. - February 02, 2018

Hospira a Pfizer Company in Rocky Mount, NC, was inspected and cited for four observations related to quality system deficiencies. These included inadequate control of mechanical equipment, use of deficient test devices affecting product testing accuracy, non-standardized historical searches for production events, and insufficient documentation of corrective and preventive actions, particularly lacking effectiveness checks for environmental monitoring excursions. The findings indicate a need for improved adherence to written procedures and more robust quality control processes.