FDA 483 - Lupin Limited (Biotech Division) - September 19, 2025

Lupin Limited (Biotech Division) in Pune, India, was cited for significant deficiencies in its manufacturing processes for drug substances and drug products. Observations included a lack of adequate written procedures for production and process controls, failures in preventing microbial contamination of sterile products, and inadequate visual inspection procedures for sterile liquid drug products. The inspection revealed systemic issues across various SOPs, decontamination, sampling, and facility maintenance, indicating a broad lack of control over critical manufacturing operations.