ICU Medical Inc – FDA 483, Aug 24, 2012

This FDA Form 483, issued to Hospira, Inc., a sterile drug manufacturer in Austin, TX, on August 24, 2012, details 19 observations from an inspection conducted between July 30 and August 24, 2012. The observations pertain to the firm's manufacture of small and large volume parenterals and irrigation products.

**Quality System:** * **Observation 1:** Failure to submit NDA-Field Alert Reports within three working days for significant changes or deterioration in distributed drug products, with multiple instances of delayed or unfiled reports for particulate contamination and container integrity breaches. * **Observation 2:** Inadequate review of batch failures, specifically regarding particulate contamination in 0.9% Sodium Chloride Injection (polyester, nylon, cotton, nitrocellulose particles), stainless steel particles in Lactated Ringers Injection, and iron oxide corrosion product in Lactated Ringers Injection, with investigations failing to determine root causes or implement adequate corrective actions. Also, no investigation into HEPA filter leaks or product impact from discoloration on the PartFill line. * **Observation 3:** Failure to follow procedures for handling drug product complaints, with 413 complaints open for over 90 days and at least 11 open for over a year, despite a target completion of 30 days.

**Drug Product:** * **Observation 4:** Lack of stability data