Sage Products Inc

CLOSEOUT LETTER Sage Products Inc MARCS-CMS 520382 — September 05, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Next Day Signature Required Product: Drugs Recipient: Recipient Name Kevin A. Lobo Recipient Title Chairman & CEO Sage Products Inc Stryker Corporation 2825 Airview Boulevard Kalamazoo , MI 49002 United States Issuing Office: Division of Pharmaceutical Quality Operations III (PHRM3) 300 River Place Suite 5900 Detroit , MI 48207 United States (313) 393-8100 Dear Mr. Lobo: The U.S. Food and Drug Administration (FDA) has completed an evaluation of Sage Products, Inc.’s corrective actions in response to our warning letter [Case #520382, July 17, 2017]. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter. You are expected to take all necessary steps to assure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. 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 Compliance Director Division of Pharmaceutical Quality Operations III cc: Mr. Donald E. Payerle Vice President and General Manager Sage Products, Inc. 3909 Three Oaks Road Cary, IL 60013 Content current as of: 09/10/2019 Regulated Product(s) Drugs