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  5. American Nutriceuticals LLC - 608998 - 01/28/2021
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American Nutriceuticals LLC MARCS-CMS 608998 —

Dietary Supplements

Recipient Name
Mr. Stephen Kravitz
American Nutriceuticals LLC

9700 NE 126th Avenue
Vancouver, WA 98682
United States

Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

United States

Dear Mr. Kravitz:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 608998, issued October 9, 2020. Based on our evaluation, it appears you have addressed the violations contained in the 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.

Carrie Lawlor
Branch Chief
Dietary Supplements and Labeling
Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Ms. Bethany R. Kennedy, Esq.
Mr. Jonathan W. Emord, Esq.
Emord & Associates
2730 South Val Vista Drive
Gilbert, AZ 85295

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