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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Contract Pharmacal Corporation - Close Out Letter 4/18/12

  

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

Public Health Service
Food and Drug Administration
 

New York District
158-15 Liberty Avenue
Jamaica, NY 11433

April 18, 2012

Matthew D. Wolf, Chief Executive Officer
Contract Pharmacal Corporation
135 Adams Avenue
Hauppauge, New York 11788-3633

Dear Mr. Wolf:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter NYK-2011-03 dated October 14, 2010. 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 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/

Dean Rugnetta
Compliance Officer
New York District

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