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CLOSEOUT LETTER

Hanna's Herb Shop MARCS-CMS 569309 —

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