FDA 483 - MACSEN DRUGS - September 06, 2024

MACSEN DRUGS, an API manufacturer in Udaipur, Rajasthan, India, received a Form 483 with eight observations highlighting significant quality system deficiencies. These include failures in ensuring product quality after a fire, inadequate stability testing, improper water system requalification, and poor environmental monitoring. The inspection also revealed serious data integrity issues, insufficient electronic equipment maintenance, a deficient preventative maintenance program, and inadequate cleaning validation for production equipment.