Pharmacy Direct, PDU

CLOSEOUT LETTER Pharmacy Direct, PDU MARCS-CMS 548625 — June 19, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Pharmacy Direct, PDU United States Issuing Office: United States 5001 Campus Drive College Park, MD 20740 June 19, 2018 Michael Rowen, President Pharmacy Direct, Inc. 8 The Green Suite 5871 Dover, DE 19901 Dear Mr. Michael Rowen: The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #548625, issued May 18, 2018. Based on our evaluation, it appears you have addressed the violations contained in the 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/ Carrie Lawlor, MPH, RD Acting Branch Chief Dietary Supplement and Labeling Assessment Branch Division of Enforcement Office of Compliance Center for Food Safety and Applied Nutrition Content current as of: 06/26/2018