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  1. Warning Letters


Mylan Laboratories Limited

Mylan Laboratories Limited

United States

Issuing Office:

United States



Black HHS-Blue FDA Logo


10903 New Hampshire Avenue
Building 51 Room 4359
Silver Spring, MD 20993-0002


July 24, 2017

Mr. Rajiv Malik
1000 Mylan Boulevard
Canonsburg, PA 15317

Reference: FEI 3007512701, FEI 3007648351, and FEI 3003813519

Dear Mr. Malik:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter: 320-15-14, August 6, 2015. 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 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.


Rafael Arroyo
Compliance Officer
Division of Drug Quality I 

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