Immusist, LLC

CLOSEOUT LETTER Immusist, LLC MARCS-CMS 610053 — February 26, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Overnight Delivery Product: Dietary Supplements Recipient: 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. Sincerely, /S/ Miriam R. Burbach District Director Program Division Director Content current as of: 03/11/2021 Regulated Product(s) Dietary Supplements