Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd.

CLOSEOUT LETTER Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd. MARCS-CMS 516381 — April 25, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd. United States Issuing Office: United States 10903 New Hampshire Avenue Silver Spring, MD 20993 April 25, 2018 Daniel (NMI) Chemouny General Manager Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd. No. 1889 Jingliu Road, Linjiang Industrial Zone Hangzhou, Zhejiang, 311228 P.R.C. Reference: FEI 3009271645 Dear Mr. Chemouny: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter: 320-17-33 dated April 5, 2017. Based on our evaluation, it appears that you have addressed the deviations contained in this 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 its implementing regulations or with other relevant legal authority. The FDA 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 deviations be observed during a subsequent inspection or through other means. Sincerely, /S/ Rebecca Parrilla Compliance Officer Division of Drug Quality I Content current as of: 04/26/2018