ECI Pharmaceuticals, LLC

CLOSEOUT LETTER ECI Pharmaceuticals, LLC MARCS-CMS 625254 — March 16, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Drugs Recipient: Recipient Name John Copanos ECI Pharmaceuticals, LLC 5311 NW 35th Terrace Ft. Lauderdale , FL 33309 United States Issuing Office: Center for Drug Evaluation and Research | CDER United States Mr. Copanos, The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2267. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter and corrected the data deficiencies. Future FDA 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 to continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during additional data review projects, future inspections, or through other means. Sincerely, /S/ Carolyn E. Becker, J.D. Director, Office of Unapproved Drugs & Labeling Compliance Center for Drug Evaluation and Research Office of Compliance U.S. Food and Drug Administration Tel: 301-796-8801 carolyn.becker@fda.hhs.gov CC: Florida District Office Content current as of: 03/22/2022 Regulated Product(s) Drugs