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Prestige Brands Holdings

Prestige Brands Holdings

United States

Issuing Office:

United States


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

Public Health Service
Food and Drug Administration
 Center for Drug Evalution and Research
Silver Spring, MD 20993 

July 5, 2017

Mary Beth Fritz
Prestige Brands Holdings, Inc.
660 White Plains Road
Tarrytown, NY, 10591 USA

Ms. Mary Beth Fritz,

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #594 and 595. 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 to 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.

Paul M. Loebach
Director, Drug Registration and Listing Staff
W051, Rm 2262 10903 New Hampshire Ave
Silver Spring, MD 20993

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