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CLOSEOUT LETTER

Syntho Pharmaceuticals, Inc.


Syntho Pharmaceuticals, Inc.

  

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

Public Health Service
Food and Drug Administration
 Silver Spring, MD  20993 

September 10, 2015
 

Mr. Van Benson
Syntho Pharmaceuticals Inc.
230 Sherwood Ave
Farmingdale, NY 11735

Mr. Benson,

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter# GDUFA-15-020. 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
Office of Compliance
Center for Drug Evaluation and Research