Hospira Inc

CLOSEOUT LETTER Hospira Inc MARCS-CMS 506761 — June 27, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Hospira Inc United States Issuing Office: United States Division of Pharmaceutical Quality Operations III 300 River Place, Suite 5900 Detroit, MI 48207 Telephone: (313) 393-8100 Fax: (313) 393-8139 June 27, 2018 UPS NEXT DAY SIGNATURE REQUIRED Mr. Ian C. Reed Chairman and CEO Pfizer Inc. 235 East 42nd St. New York, NY 10017 Dear Mr. Reed: The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hospira Inc., a Pfizer Company at 1776 Centennial Drive, McPherson, Kansas, from October 16-27, 2017. The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (Case 506761). Any continued concerns regarding your Warning Letter response will be addressed in additional correspondence. Based on our current evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Nicholas F. Lyons Director Compliance Branch Division of Pharmaceutical Quality Operations Division III cc: Mr. Jonathan J. Rushford Vice President Operations/Site Head 1776 Centennial Dr. McPherson, KS 67460 Content current as of: 07/25/2018