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  5. Wickliffe Pharmaceutical, Inc. - 08/12/2016
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CLOSEOUT LETTER

Wickliffe Pharmaceutical, Inc.

Recipient:
Wickliffe Pharmaceutical, Inc.

United States

Issuing Office:

United States

  

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

 
 Food and Drug Administration
Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
         FAX: (513) 679-2761

August 12, 2016

VIA UPS


RE: WARNING LETTER
CIN-14-432082-20


Jacqueline S. Bernard, President and Owner
Wickliffe Pharmaceutical, Inc.
4340 Georgetown Road
Lexington, KY 40511

Dear Ms. Bernard:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CIN-14-432082-20, dated August 14, 2014. Based on our evaluation, it appears that you have addressed the violation(s) 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.

/S/

Stephen J. Rabe
Compliance Officer