Hospira Costa Rica Ltd. – FDA Warning Letter, Apr 19, 2012

On August 22, 2012, the FDA issued a Warning Letter to Hospira, Inc. following an inspection of their Costa Rica facility from April 16-19, 2012. The inspection revealed that Hospira's Symbiq, Plum, Gemstar, and Lifecare PCA infusion pumps and intravascular administration sets were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation 21 CFR Part 820.

Key violations included: 1. **Failure to identify corrective and preventive actions (21 CFR 820.100(a)(3)):** Despite a February 2011 recall for Plum pump audible alarm failures and a supplier corrective action, multiple complaints of no audible alarms persisted in March 2012. 2. **Failure to implement and record changes for quality problems (21 CFR 820.100(a)(5)):** * An obsolete instruction remained in a procedure (502-95004-006) related to a September 2011 recall (Z-3284-2011) for unrestricted free-flow in Plum pumps. * A required visual inspection for regulator closure installation, a corrective action for recall Z-