Invisi Smart Technologies UK LTD

CLOSEOUT LETTER Invisi Smart Technologies UK LTD MARCS-CMS 614512 — February 17, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Ms. Saba Yussouf Recipient Title CEO Invisi Smart Technologies UK LTD 112 Cumberland House 80 Scrubs Lane London NW10 6RF United Kingdom Issuing Office: Center for Devices and Radiological Health United States Dear Ms. Yussouf: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS #614512 dated August 24, 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 yours, /S/ Cynthia J. Chang, Ph.D. Director DHT 4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Content current as of: 02/23/2022 Regulated Product(s) Medical Devices