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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Looking to provide evidence of its extended measures to improve quality, compliance and oversight, Lupin has received positive news from the FDA for its US-based manufacturing facility in Somerset, New Jersey.
As the COVID-19 pandemic wore on, industry clamored for the US FDA to re-inspect troubled drug manufacturing plants remotely if need be to clear them for new approvals. Now FDA investigators are out in force and early returns from Sun, Aurobindo, Lupin and Sterling suggest these re-inspections will be as tough as ever.
Lupin hires former nemesis at FDA, how Baker exposed Hisun’s ‘full investigation,’ Cetylite’s many methods for overcoming OOS results, old school inspection-driven recalls at Vitae Enim Vitae Scientific and a critique of Catalent filling line’s non-deliberate response to the pandemic.