Raritan Pharmaceuticals, Inc.

CLOSEOUT LETTER Raritan Pharmaceuticals, Inc. MARCS-CMS 516099 — March 12, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Raritan Pharmaceuticals, Inc. United States Issuing Office: United States Division of Pharmaceutical Quality Operations I 10 Waterview Blvd, 3rd FL Parsippany, NJ 07054 Telephone: (973) 331-4900 FAX: (973) 331-4969 March 12, 2018 VIA UPS Next Day Air Dr. Vin K. Nayak President Raritan Pharmaceuticals, Inc. 8 Joanna Ct. East Brunswick, New Jersey 08816 Dear Dr. Nayak: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 17-NWJ-09, dated June 20, 2017. Based on our evaluation, it appears that you have addressed the violation(s) 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 it 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/ Liatte Krueger Closs Compliance Officer OPQO/PHRM1-CB Content current as of: 03/12/2018