Induction Therapies, LLC

CLOSEOUT LETTER Induction Therapies, LLC MARCS-CMS 616487 — October 31, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UNITED PARCEL SERVICE Product: Medical Devices Recipient: Recipient Name Angelia L. Inscoe Recipient Title Chief Executive Officer Induction Therapies, LLC 1920 Stanley Gault Pkwy Suite 100 Louisville , KY 40223 United States Issuing Office: Center for Devices and Radiological Health United States Dear Ms. Inscoe: The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter, CMS# 616487, dated November 23, 2021 for your firm’s Louisville, KY location. 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/ Gina M. Brackett Director, Compliance Branch Office of Medical Devices & Radiological Health Division One - East Content current as of: 11/08/2022 Regulated Product(s) Medical Devices