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Immusist, LLC MARCS-CMS 610053 —

Delivery Method:
Overnight Delivery
Dietary Supplements

Recipient Name
James P. Gates
Recipient Title
Managing Member
Immusist, LLC

4810 Point Fosdick Drive NW
Suite 330
Gig Harbor, WA 98335
United States

Issuing Office:
Division of Human and Animal Food Operations West VI

United States

Dear Mr. Gates:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 610053, dated October 15, 2020. 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.

Miriam R. Burbach
District Director
Program Division Director

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