Olympus Medical Systems Corporation

CLOSEOUT LETTER Olympus Medical Systems Corporation MARCS-CMS 546986 — April 04, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Julien Sauvagnargues Recipient Title President & CEO Olympus Medical Systems Corporation 3500 Corporate Parkway Center Valley , PA 18034 United States Issuing Office: Center for Devices and Radiological Health United States Dear Julien Sauvagnargues: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 546986, dated March 9, 2018). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. 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 yours, /S/ Courtney H. Lias, Ph.D. Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Center for Devices and Radiological Health CC: Laura Storms Vice President, Regulatory Affairs & Quality Assurance Olympus Corporation of the Americas 3500 Corporate Parkway Center Valley, Pennsylvania 18034 Kota Nozue Postmarket Surveillance Project Leader 3500 Corporate Parkway P.O. Box 610 Center Valley, Pennsylvania 18034 Akihiro Okubo, President Olympus Medical Systems Corporation 2951 Ishikawa-cho, Hachioji-shi Tokyo 192-8507, Japan Content current as of: 04/08/2022 Regulated Product(s) Medical Devices