Pure Source LLC

CLOSEOUT LETTER Pure Source LLC MARCS-CMS 555240 — November 15, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Joel J. Meyerson Recipient Title Owner Pure Source LLC 9750 NW 17th Street Doral , FL 33172-2753 United States Issuing Office: Center for Drug Evaluation and Research United States Mr. Meyerson: The Food and Drug Administration has completed the evaluation of corrective actions in response to our Warning Letter (WL # 555240), dated February 20, 2019. 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/ John W. Diehl, M.S. Director, Compliance Branch Office of Pharmaceutical Quality Operations, Division II CC: Renee Alsobrook, Chief Department of Business and Professional Regulation Division of Drugs, Devices and Cosmetics Compliance and Enforcement 2601 Blair Stone Road Tallahassee, Florida 32399-1047 Content current as of: 11/19/2019 Regulated Product(s) Drugs