Surmasis Pharmaceutical

CLOSEOUT LETTER Surmasis Pharmaceutical MARCS-CMS 553686 — June 22, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Next Day Product: Drugs Recipient: Recipient Name Mr. Lorne C. Scharnberg Recipient Title CEO Surmasis Pharmaceutical 4020 Gannett Avenue Des Moines , IA 50321 United States Issuing Office: Division of Pharmaceutical Quality Operations III United States (313) 393-8100 Dear Mr. Scharnberg: The Food and Drug Administration has completed evaluation of your corrective actions in response to our Warning Letter #553686 dated November 6, 2018. Based on our 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 of Compliance Division of Pharmaceutical Quality Operations III Content current as of: 06/29/2020 Regulated Product(s) Drugs