FDA EIR - Hospira, Inc., A Pfizer Company - May 25, 2011

An FDA "For Cause" inspection was conducted at Hospira Inc. in McPherson, KS, from May 24-25, 2011. The inspection was initiated by MedWatch reports alleging renal toxicity and particulates associated with Sterile Vancomycin HCL IV, operating under an assignment from the CDER Office of Generic Drugs and ORA and CP 7356.021. The review also addressed follow-up items from a previous inspection concerning Hydromorphone, including issues like charring from the sealing process and potential metal fragments from needle strikes, as well as unlabeled vials. For the Vancomycin HCL IV, Hospira Inc.'s internal investigations, which involved examining batch records, final release testing, and reserve samples, indicated no manufacturing defects; all product lots met USP specifications. A complaint of cellulose fiber in a Vancomycin vial was traced to the stopper manufacturer. A notable procedural issue was the firm's lack of direct receipt of MedWatch reports from the Agency. Despite the initial serious allegations, no FDA Form 483 observations were issued during this inspection. Verbal observations regarding minor issues were discussed with management, who committed to making corrections. Ten samples of the implicated Sterile Vancomycin HCL IV lots were collected by the FDA for independent laboratory analysis.