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  5. Invisi Smart Technologies UK LTD - 614512 - 02/17/2022
  1. Warning Letters

CLOSEOUT LETTER

Invisi Smart Technologies UK LTD MARCS-CMS 614512 —

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

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