FDA 483 - MACSEN DRUGS - September 06, 2024

MACSEN DRUGS, an API manufacturer in Udaipur, India, received a Form 483 citing significant deficiencies across its quality, laboratory, and production systems. Key issues include releasing fire-impacted products without retesting, inadequate stability testing after chamber failures, and failures in water system requalification and environmental monitoring. The firm also demonstrated poor data integrity practices, an inadequate preventative maintenance program, and insufficient cleaning validation for production equipment.