FDA 483 - SHREEPATI PHARMACEUTICALS PRIVATE LIMITED - December 02, 2023

An FDA inspection of Shreepati Pharmaceuticals Private Ltd. in Dhar District, Madhya Pradesh, India, an intermediate manufacturer, revealed significant deficiencies. Observations included contaminated manufacturing equipment, lack of stability data for intermediates, failure to retain essential records and reserve samples, and inadequate demonstration of water system suitability. These issues highlight serious concerns regarding the firm's quality control and manufacturing processes.