Inspections, Compliance, Enforcement, and Criminal Investigations
Mylan LLC. - Close Out Letter 6/7/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|466 Fernandez Juncos Avenue|
San Juan, Puerto Rico, 00901
June 07, 2013
Return Receipt Requested
Mr. Rajiv Malik
1500 Corporate Drive
Canonsburg, PA 15317
Dear Mr. Malik:
We have completed an evaluation of your firm's corrective actions in response to our Warning Letter 12-SJN-WL-01 dated October 13, 2011. Based on our evaluation, it appears that you have 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.
Should you have questions and/or comments regarding this matter, please feel free to contact me at the district office address provided above in the letterhead. You may also contact Mr. Carlos A. Medina, Compliance Officer at telephone number 787-474-9538 or at email@example.com.
Director of Compliance
San Juan District Office