Westminster International Ltd

CLOSEOUT LETTER Westminster International Ltd MARCS-CMS 613566 — March 25, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Peter Fowler Westminster International Ltd Westminster House, Blacklocks Hill (Banbury Lane) Banbury, Oxfordshire OX17 2BS United Kingdom p.fowler@wg-plc.com Issuing Office: Center for Devices and Radiological Health United States Secondary Issuing Offices United States Dear Peter Fowler: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS# 613566, dated March 4, 2021. 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/ Michael J. Hoffmann Director Office of Health Technologies 3 - Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Food and Drug Administration Content current as of: 03/31/2025 Regulated Product(s) Medical Devices