FDA 483 - Lupin Limited - July 11, 2023

Lupin Limited in Nagpur, India, a prescription drug manufacturer, was cited for significant deficiencies in its laboratory controls system. Observations included inadequate security for electronic laboratory data, allowing unauthorized modification and reprocessing of data without justification, and a high number of aborted analytical sequences lacking scientific rationale. Additionally, the firm failed to maintain complete records for samples received for testing, including descriptions, quantities, and receipt dates.