FDA 483 - Lantech Pharmaceuticals Ltd. - March 15, 2019

Lantech Pharmaceuticals Ltd., an API manufacturer in Chittivalasa, India, received a Form FDA 483 with nine observations during an inspection from March 6-15, 2019. The observations highlight significant deficiencies across quality systems, including inadequate investigations, poor equipment cleaning, lack of electronic data control, insufficient Quality Unit oversight, and absence of process validation for solvent recovery. These issues indicate a systemic failure to ensure product quality and data integrity.