Aphena Pharma Solutions-Tennessee, LLC

CLOSEOUT LETTER Aphena Pharma Solutions-Tennessee, LLC MARCS-CMS 542310 — January 31, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Drugs Recipient: Aphena Pharma Solutions-Tennessee, LLC United States Issuing Office: United States 10903 New Hampshire Avenue Silver Spring, MD 20993 January 31, 2018 Chris Campbell Aphena Pharma Solutions - Tennessee, LLC 1920 Fisk Road Cookeville, TN 38506 Mr. Campbell, The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #1190 and 1161. 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 a subsequent inspection or through other means. Sincerely, /S/ Maria Rossana (Rosemary) R. Cook Director Office of Program and Regulatory Operations Office of Compliance Center for Drug Evaluation and Research Telephone: 301-348-3968 maria.cook@fda.hhs.gov Content current as of: 02/02/2018 Regulated Product(s) Drugs