Sovereign Laboratories, LLC

CLOSEOUT LETTER Sovereign Laboratories, LLC MARCS-CMS 606490 — August 21, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Food & Beverages Recipient: Recipient Name Douglas Wyatt Sovereign Laboratories, LLC 70 Sheath Dr Sedona , AZ 86336 United States Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN) United States Dear: Mr. Douglas Wyatt, The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our COVID-19 Warning Letter Re: 606490, issued June 15, 2020. Based on our evaluation, it appears you have addressed the violation(s) 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 Supplement and Labeling Assessment Branch Division of Enforcement Office of Compliance Center for Food Safety and Applied Nutrition Food and Drug Administration cc: HFS-605 CMS # 606490/ WA# 331763 FEI# 3014751882 Content current as of: 09/07/2021 Regulated Product(s) Food & Beverages