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CLOSEOUT LETTER

Pharmaceutical Associates Inc May 06, 2016

Pharmaceutical Associates Inc - Close Out Letter 5/6/16


Pharmaceutical Associates Inc

  

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

 
 Food and Drug Administration
Center for Drug Evaluation and Research
Silver Spring. MD 20993-0002

May 6, 2016

Becky Ochenreider
Pharmaceutical Associates, Inc.
201 Delaware Street
Greenville, SC 29605

Ms. Ochenreider,

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #223. 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 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/

Paul Loebach, Director
Drug Registration and Listing Staff
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration