FDA 483 - Lupin Limited - January 10, 2020

An FDA inspection of Lupin Limited, a non-sterile drug manufacturer in Mihan, India, revealed significant deficiencies in their quality control processes. The firm failed to thoroughly investigate out-of-specification (OOS) results, often invalidating them without establishing a definitive root cause. Additionally, established laboratory control procedures for handling OOS results were not consistently followed by Quality Control personnel.