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CLOSEOUT LETTER

Homeodynamics, LLC MARCS-CMS 539270 —

Product:
Drugs
Recipient:
Recipient Name
Michael J. Leger
Recipient Title
Owner and President
Homeodynamics, LLC

7137 Lindfield Road
Madison, WI 53719-2132
United States

Issuing Office:
Division of Human and Animal Food Operations West I (HAFW1)

250 Marquette Avenue
Suite 600
Minneapolis, MN 55401
United States

612) 334-4100

Dear Mr. Leger:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 539270 dated February 20, 2018. Based on our evaluation, it appears that you have addressed the violations 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/
Boun M. Xiong
Compliance Officer, West Division 1 - CB
Office of Human and Animal Foods Operations

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