Lupin Limited (Biotech Division) – FDA 483, Sep 19, 2025
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
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