FDA 483 - MACSEN DRUGS - September 06, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 7aec2348-bffd-437e-b000-eec912c99cb5