483
Lupin LimitedLupin Limited – FDA 483, Jan 10, 2020
Record Details
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.
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ID · c1e1d43b-a1f0-48da-9195-f9a776d577b2
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