FDA 483 - Lupin Limited - September 16, 2025

Lupin Limited in Nagpur, India, received a Form 483 with six observations during an inspection from September 5-16, 2025. The observations primarily concern significant deficiencies in aseptic processing validation, environmental monitoring, quality control procedures, and stability testing methods for sterile drug products. These issues indicate a lack of adequate controls to prevent microbiological contamination and ensure product quality and data integrity.