Mylan Laboratories Limited, (Nashik FDF)

CLOSEOUT LETTER Mylan Laboratories Limited, (Nashik FDF) July 18, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Mylan Laboratories Limited, (Nashik FDF) United States Issuing Office: United States 10903 New Hampshire Avenue Silver Spring, MD 20993 July 18, 2018 Mr. Rajiv Malik President Mylan Pharmaceuticals, Inc. 1000 Mylan Boulevard Canonsburg, PA 15317 Reference: FEI 3005587313 Dear Mr. Malik: The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-17-32 dated March 31, 2017. Based on our evaluation, it appears that you have addressed the violations 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 violations be observed during a subsequent inspection or through other means, Sincerely, /S/ Joseph Lambert Compliance Officer Division of Drug Quality I Content current as of: 08/06/2018