Fagron, Inc

CLOSEOUT LETTER Fagron, Inc MARCS-CMS 545906 — June 13, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Rafael Padilla Recipient Title CEO Fagron, Inc Fagron BV Lichtenauerlaan 182 3062 ME Rotterdam Netherlands Issuing Office: Center for Drug Evaluation and Research 300 River Place Suite 5900 Detroit , MI 48207 United States (313) 393-8100 Dear Mr. Padilla: The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [Case# 545906] dated August 29, 2018. Based on our evaluation, it appears that you have addressed the violation(s) 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 Compliance Director Division of Pharmaceutical Quality Operations III cc: Teresa Fiedler, President Fagron North America Fagron Inc. 2400 Pilot Knob Road St. Paul, MN 55120 Content current as of: 06/17/2019 Regulated Product(s) Drugs