Novel Laboratories, Inc. d.b.a Lupin Somerset

CLOSEOUT LETTER Novel Laboratories, Inc. d.b.a Lupin Somerset MARCS-CMS 613385 — April 14, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Next Day Product: Drugs Recipient: Recipient Name Ms. Vinita D. Gupta Recipient Title Group President-CEO Novel Laboratories, Inc. d.b.a Lupin Somerset B/4 Laxmi Towers Bandra Kurla Complex, Bandra (E) Mumbai 400051 India vinitagupta@lupin.com Issuing Office: Office of Pharmaceutical Quality Operations Division I United States Dear Ms. Gupta: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS # 613385], dated June 11, 2021. Based on our evaluation, it appears that you have adequately addressed the violations contained in this Warning Letter. 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. Respectfully, /S/ Lisa Harlan Program Division Director U.S. Food and Drug Administration OPQO Division I CC: Mr. Ronald W. Overhiser Vice President-Operations and Site Head Novel Laboratories, Inc. d.b.a. Lupin 400 Campus Drive Somerset, NJ 08873 RonaldOverhiser@lupin.com Content current as of: 04/19/2023 Regulated Product(s) Drugs