BHP Holdings Inc. dba BioPure Healing Products

CLOSEOUT LETTER BHP Holdings Inc. dba BioPure Healing Products MARCS-CMS 597687 — March 28, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Overnight Delivery Product: Dietary Supplements Food & Beverages Recipient: Recipient Name Brandy D. Floyd Recipient Title Chief Executive Officer BHP Holdings Inc. dba BioPure Healing Products 18538 142nd Avenue NE Woodinville , WA 98072 United States Issuing Office: Division of Human and Animal Food Operations West VI United States Dear Ms. Floyd: The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS 597687, dated June 17, 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: 04/01/2022 Regulated Product(s) Dietary Supplements Food & Beverages