Lupin’s Corporate Quality Oversight Questioned In FDA Warning Letter
Two-month inspection during pandemic highlighted cross-contamination risks and process validation shortfalls at New Jersey plant.
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Agency demands review of invalidated out-of-specification findings as root causes of failures continue to elude Indian drugmaker at multiple facilities.
Warning letter points to excessive in-process hold times as likely cause of out-of-specification results at two Lupin plants that the firm dismissed as outliers or blamed on analysts. FDA directs Lupin to eliminate excessive hold times and study whether they were problem.
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