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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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DPT Lakewood, LLC - Close Out Letter 2/19/13


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) 331-4900

February 19, 2013

Mr. Eugene Ciolfi
Vice President and General Manager
DPT Lakewood, LLC
1200 Paco Way
Lakewood, New Jersey 08701-5938

Dear Mr. Ciolfi:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter No. 12-NWJ-21, dated August 27, 2012. Based on our evaluation, it appears that you have addressed the violations contained in the 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 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.



CAPT Joseph F. McGinnis
Director, Compliance Branch
New Jersey District