Similasan AG

CLOSEOUT LETTER Similasan AG MARCS-CMS 658878 — July 29, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 1000110034 Product: Drugs Recipient: Recipient Name Dr. Urs Lehmann Recipient Title CEO Similasan AG Industriestrasse 27 Sarnen 6060 Switzerland Urs.lehmann@similasan.swiss Issuing Office: Center for Drug Evaluation and Research | CDER United States Secondary Issuing Offices United States Dear Dr. Lehmann and Mr. Quail: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 658878, dated September 11, 2023. 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 FDA 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/ Kevin Maguire Compliance Officer Division of Drug Quality III Office of Manufacturing Quality Content current as of: 07/30/2026 Regulated Product(s) Drugs