Best Bentonite

CLOSEOUT LETTER Best Bentonite MARCS-CMS 494502 — November 23, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS NEXT DAY DELIVERY Reference #: 2016-DAL-WL-26 Product: Drugs Recipient: Recipient Name Marshall A. Dunlap Recipient Title Owner Best Bentonite Best Bentonite 11650 Otis Rd Guthrie , OK 73044 United States Issuing Office: United States Marshall A. Dunlap - Owner Best Bentonite 11650 Otis Rd Guthrie, OK 73044 Mr. Dunlap: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 2016-DAL-WL-26 dated June 17, 2016. Based on our evaluation during, it appears that you have addressed the violations contained in this Warning Letter related to your marketing of Best Bentonite. 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/ LCDR John W. Diehl, M.S. Director, Compliance Branch Office of Pharmaceutical Quality Operations, Division II Content current as of: 11/30/2018 Regulated Product(s) Drugs