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  5. Skin Sheek - 612682 - 03/10/2023
  1. Warning Letters

CLOSEOUT LETTER

Skin Sheek MARCS-CMS 612682 —

Product:
Medical Devices
Recipient:
Recipient Name
Meredith Dodini Hult
Recipient Title
President
Skin Sheek

4431 W. Spruce Court
Highland, UT 84003
United States

Issuing Office:
Center for Devices and Radiological Health

United States

Dear Ms. Hult:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 612682, dated January 28, 2022). 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/
For Binita S. Ashar, MD, MBA, FACS
Director Office of Surgical and Infection Control Devices
Center for Devices and Radiological Health

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