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THE PHARMA REVIEW (NOVEMBER DECEMBER 2013)

USFDA Warning Letter: A Primer

Prashant B Musmade, Manthan D Janodia, Swapnil J Dengale, P Chandra Sekhar, Virendra S Ligade & N Udupa

Introduction: The Warning Letter provides firms and individuals opportunity to take corrective actions where the USFDA feels that regulatory violation has occurred. Warning Letters are informal and voluntary and it is an opportunity for manufacturer to take remedy error before the agency takes an enforcement action. There are primarily three basic types of Warning Letters issued by USFDA1. 

 

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