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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The US FDA conducted seven drug inspections in India from February through August 2021 and front-line Indian firms are hopeful things will pick up further and that some pre-approval inspections may happen virtually. But no foreign surveillance inspections are expected to be conducted by FDA inspectors traveling from the US before September 2021.
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.