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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Rasi Laboratories, Inc. - Close Out Letter 8/16/11

  

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

 

August 16, 2011

Mr. Surendra Vallabhaneni, Director of Operations
Rasi Laboratories, Inc.
20 Roosevelt Avenue
Somerset, NJ 08873

Dear Mr. Vallabhaneni: 

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 11-NWJ-10 dated February 17, 2011. Based on our evaluation and a review of your written response dated August 11, 2011, 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/

Joseph F. McGinnis, R.Ph
Acting Director of Compliance
New Jersey District