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  5. Duncan's Botanical Products, Inc. - 519077 - 10/11/2019
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CLOSEOUT LETTER

Duncan's Botanical Products, Inc. MARCS-CMS 519077 —

Delivery Method:
VIA UPS
Product:
Dietary Supplements

Recipient:
Recipient Name
Brent W. Duncan
Recipient Title
Owner and President
Duncan's Botanical Products, Inc.

1231 E. Smithville Road
Bloomington, IN 47401
United States

Issuing Office:
Center for Food Safety and Nutrition

550 W. Jackson Blvd.
Suite 1500
Chicago, IL 60661
United States

(312) 353-5863

Dear Mr. Duncan,

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter (2017-DET-06, dated May 8, 2017). 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/
Byron Ho, DVM
Compliance Officer
Office of Human and Animal Food
Division East 6