American Nutriceuticals LLC

CLOSEOUT LETTER American Nutriceuticals LLC MARCS-CMS 608998 — January 28, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Dietary Supplements Recipient: 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. Sincerely, /S/ 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 CC: Ms. Bethany R. Kennedy, Esq. Mr. Jonathan W. Emord, Esq. Emord & Associates 2730 South Val Vista Drive Gilbert, AZ 85295 Content current as of: 02/01/2021 Regulated Product(s) Dietary Supplements