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  5. Aphena Pharma Solutions-Tennessee, LLC - 542310 - 01/31/2019
  1. Warning Letters

CLOSEOUT LETTER

Aphena Pharma Solutions-Tennessee, LLC MARCS-CMS 542310 —

Product:
Drugs
Recipient:
Aphena Pharma Solutions-Tennessee, LLC

United States

Issuing Office:

United States

 

   

Black HHS-Blue FDA Logo

 

 
 
10903 New Hampshire Avenue
Silver Spring, MD 20993 

January 31, 2018

Chris Campbell
Aphena Pharma Solutions - Tennessee, LLC
1920 Fisk Road
Cookeville, TN 38506

Mr. Campbell,

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #1190 and 1161. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter and corrected the data deficiencies. Future FDA 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 to 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/

Maria Rossana (Rosemary) R. Cook
Director
Office of Program and Regulatory Operations
Office of Compliance
Center for Drug Evaluation and Research
Telephone: 301-348-3968
maria.cook@fda.hhs.gov

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