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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Vertical Pharmaceuticals Inc. Close out Letter 3/8/11

  

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

Public Health Service
Food and Drug Administration
 Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054 

 

Telephone (973) 331-4905


March 8, 2011


Mr. Steven Squashic,President
Vertical Pharmaceuticals Inc.
2400 Main Street Extension, Suite 6
Sayreville, NJ 08872


Dear Mr. Squashic:


The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 10-NWJ-05 dated February 18, 2010. 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.


Sincerely,
/S/
Nancy Rolli
Director of Compliance
New Jersey District