U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. ANDAPharm, LLC - Close Out Letter 10/10/14
  1. Compliance Actions and Activities

CLOSEOUT LETTER

Andapharm, LLC Oct 10, 2014

ANDAPharm, LLC - Close Out Letter 10/10/14


Andapharm, LLC

  

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

 
 Food and Drug Administration
Silver Spring, MD 20993

 

October 10, 2014


Mr. Fedner Destine
ANDAPharm
5315 NW 35th Terrace
Fort Lauderdale FL 33309


Dear Mr. Destine,

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #GUDFA-14-014. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections or 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/ 

Michael Levy
Deputy Director for Policy and Analysis
Office of Compliance
Center for Drug Evaluation and Research