Navinta, LLC

CLOSEOUT LETTER Navinta, LLC MARCS-CMS 498400 — March 05, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Navinta, LLC United States Issuing Office: United States 10903 New Hampshire Avenue Silver Spring, MD 20993 March 5, 2018 UNITED PARCEL SERVICE Dr. Mahendra Patel, CEO Navinta, LLC 1499 Lower Ferry Road Ewing, NJ 08618‐1414 Dear Dr. Patel: The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated September 26, 2016 (Ref: 16‐NWJ‐16). Based on our evaluation, it appears that 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 from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its regulations or with other relevant legal authorities. The Agency expects you 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/ LaShanda Long, M.S. Branch Chief Postmarketing Safety Branch Division of Enforcement and Postmarketing Safety Office of Scientific Investigations Office of Compliance Center for Drug Evaluation and Research Food and Drug Administration Building 51, Room 5356 10903 New Hampshire Avenue Silver Spring, MD 20993‐0002 Content current as of: 04/19/2018