Celloxess LLC

CLOSEOUT LETTER Celloxess LLC MARCS-CMS 495253 — February 11, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: 16-NWJ-11 Product: Dietary Supplements Drugs Recipient: Recipient Name Dr. Parviz Gharagozloo Celloxess LLC 830 Bear Tavern Rd Ewing , NJ 08628 United States Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN) 5001 Campus Drive College Park , MD 20740 United States Dear Dr. Gharagozloo: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, 16-NWJ-11, dated July 22, 2016. 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, Carrie Lawlor /S/ 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: 02/18/2020 Regulated Product(s) Dietary Supplements Drugs