FDA 483 - Malladi Drugs & Pharmaceuticals Ltd. Unit 1 - November 07, 2022

An FDA inspection of Malladi Drugs & Pharmaceuticals Limited, Unit-1 in Ranipet, India, revealed four significant observations related to manufacturing practices. Deficiencies included unscientific sampling procedures, inadequate validation protocols for equipment, lack of verification for critical cell count operations, and poor facility maintenance with visible contamination in a critical area. These issues indicate a need for improved quality control and facility upkeep.