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  5. ICA Health, LLC - 614383 - 10/16/2023
  1. Warning Letters

CLOSEOUT LETTER

ICA Health, LLC MARCS-CMS 614383 —

Product:
Dietary Supplements
Recipient:
Recipient Name
Dr. James L. Wilson
Recipient Title
Owner/Manager
ICA Health, LLC
Future Formulations, LLC

1340 E. 20th Street
Tucson, AZ 85719-6710
United States

Issuing Office:
Office of Human and Animal Foods Operations – Division West 4

United States

Dear Dr. Wilson,

The Food and Drug Administration has completed an evaluation of ICA Health, LLC and Future Formulations, LLC corrective actions in response to our Warning Letter (CMS case #614383) issued on September 20, 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,
/S/
E.Mark Harris
Program Division Director
Office of Human and Animal Food Operations – West
Division 4

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