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  5. Induction Therapies, LLC - 616487 - 10/31/2022
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Induction Therapies, LLC MARCS-CMS 616487 —

Delivery Method:
Medical Devices

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

Gina M. Brackett
Director, Compliance Branch
Office of Medical Devices & Radiological Health Division One - East

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