FDA 483 - Lupin Limited - September 18, 2021

Lupin Limited, a drug product manufacturer in Verna, Goa, India, received a Form 483 with seven observations. The inspection revealed significant deficiencies in quality control, including inadequate investigations into discrepancies, insufficient in-process material testing, and a failure to validate component supplier test results. Additionally, issues were noted with annual product reviews not including returned products, non-adherence to stability programs, and uncontrolled access to labeling materials.