Hanna's Herb Shop

CLOSEOUT LETTER Hanna's Herb Shop MARCS-CMS 569309 — November 25, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Overnight Reference #: HAF4W(DEN)-19-06-WL Product: Dietary Supplements Recipient: Recipient Name Thomas M. Brown Recipient Title President Hanna's Herb Shop 5684 Valmont Rd Boulder , CO 80301 United States Issuing Office: Office of Human and Animal Food Operations Division IV West United States Dear Mr. Brown: The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter HAF4W(DEN)-19-06-WL, dated March 5, 2019. Based on our evaluation, it appears that you have addressed the violation(s) 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/ LaTonya M. Mitchell, PhD Program Division Director Office of Human and Animal Food Operations - Division IV West Content current as of: 12/09/2019 Regulated Product(s) Dietary Supplements