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CLOSEOUT LETTER

Akorn, Inc. Oct 24, 2014

Akorn, Inc. - Close Out Letter 10/24/14


Akorn, Inc.

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Food and Drug Administration
 Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863

 

October 24, 2014


Raj Rai
Chief Executive Officer
Akorn, Inc.
1925 West Field Court, #300
Lake Forest, IL 60045


Dear Mr. Rai:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, CHI-1-13, dated October 2, 2012. 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.

 

Sincerely

/S/

Scott J. MacIntire
District Director