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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Hi-Tech Pharmacal Co., Inc. - Close Out Letter 9/5/11


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 Ave.
Jamaica, NY 11433

September 5, 2011 

Mr. David Seltzer
President and Chief Executive Officer
Hi-Tech Pharmacal Co., Inc.
369 Bayview A venue
Amityville, New York 11701

Dear Mr. Seltzer:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter NYK-2010-21 dated June 26, 20120. 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.



Lillian C. Aveta
Compliance Officer
New York District