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  5. Leaf of Life LLC - 619191 - 01/18/2023
  1. Warning Letters

CLOSEOUT LETTER

Leaf of Life LLC MARCS-CMS 619191 —

Delivery Method:
VIA UPS
Product:
Dietary Supplements
Recipient:
Recipient Name
Michael A. Bolan
Recipient Title
Owner
Leaf of Life LLC

12355 Country Glen Lane
Creve Coeur, MO 63141
United States

Issuing Office:
Office of Human and Animal Food- West Division II

United States

Dear Mr. Bolan,

The Food and Drug Administration has completed an evaluation of Leaf of Life LLC corrective actions in response to our Warning Letter (CMS case # 619191 dated August 4, 2022) during our investigation conducted on October 27, 2022. 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/
LaTonya M. Mitchell, Ph.D.
Program Division Director
Office of Human and Animal Foods-West Division 2

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