FDA 483 - Lupin Limited (Biotech Division) - September 19, 2025
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.
Lupin Limited (Biotech Division) in Pune, Maharashtra, India, was cited for significant deficiencies in its drug substance and drug product manufacturing operations. The inspection revealed inadequate written procedures for production and process controls, failures in preventing microbial contamination during aseptic processing, and insufficient visual inspection procedures for sterile liquid drug products. Overall, the firm demonstrated a lack of adherence to established SOPs and protocols, indicating a compromised state of quality assurance and facility control.
ID · 2f83ecb9-d4dc-4906-8888-837267f95c95