FDA 483 - Synergene Active Ingredients Pvt. Ltd. (Unit II)

An FDA inspection of Synergene Active Ingredients Pvt Ltd, an API manufacturer in Parawada Mandal, India, revealed significant deficiencies in quality control and manufacturing processes. Observations included inadequate investigations for out-of-specification results and laboratory incidents, insufficient cleaning and sanitization of non-dedicated equipment, and incomplete documentation of critical manufacturing steps. These issues indicate a lack of robust quality systems to ensure product quality and prevent contamination.