FDA 483 - Hospira, Inc. - January 19, 2010

During an inspection from January 12-19, 2010, at Hospira, Inc.'s medical device and drug manufacturing facility in Rocky Mount, NC, the FDA issued a Form 483 detailing significant observations. The primary issues centered on inadequate control procedures and documentation for manufacturing processes, particularly process validation. The company failed to establish validated solution tank mixing processes for products like Amridate, Amikacin, Droperidol, and heparin lock flush solutions, which could cause variability in product characteristics. Furthermore, in-process specifications were not determined using appropriate statistical methods, and critical control parameters for certain processes were not adequately identified or evaluated. Significant documentation deficiencies were also noted, including the destruction of batch records for a 2003 Heparin Lock Flush Solution mixing validation study. Moreover, quality problems, such as visible particulate found during a validation, were not properly investigated or communicated internally to prevent recurrence. These observations indicate non-compliance with the regulatory framework for manufacturing and quality control. Hospira, Inc. formally committed to correcting all identified issues.