Stanmore Implants Worldwide Ltd.

CLOSEOUT LETTER Stanmore Implants Worldwide Ltd. MARCS-CMS 444402 — May 03, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UNITED PARCEL SERVICE Product: Medical Devices Recipient: Recipient Name Michael Mainelli Recipient Title Chief Executive Officer Stanmore Implants Worldwide Ltd. 210 Centennial Avenue Elstree WD6 3SJ United Kingdom Issuing Office: Center for Devices and Radiological Health 10903 New Hampshire Avenue Silver Spring , MD 20993 United States Dear Mr. Mainelli: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (Case #444402), issued on November 26, 2014. 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/ CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 Office of Product Evaluation and Quality Center for Devices and Radiological Health cc: Establishment File Home District of Corporate HQ (or of receiving firm if issued by a Center) FOI Office for Posting CMS case file (electronic copy) Content current as of: 05/31/2019 Regulated Product(s) Medical Devices