FDA 483 - Solara Active Pharma Sciences Limited - March 07, 2020

An FDA inspection of Solara Active Pharma Science Ltd. in Kudikadu Village, Cuddalore, India, revealed significant deficiencies across its active pharmaceutical ingredient manufacturing operations. The firm failed to conduct adequate investigations into genotoxic impurities, maintain a robust cleaning validation program, properly calibrate laboratory instruments, ensure the accuracy and reliability of analytical testing, and validate analytical procedures. These issues collectively point to a critical lack of quality unit oversight, impacting the integrity and quality of drug substances.