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Lupin’s Corporate Quality Oversight Questioned In FDA Warning Letter

 
• By Bowman Cox

Two-month inspection during pandemic highlighted cross-contamination risks and process validation shortfalls at New Jersey plant.

Warning hazard sign and signage man falling
lupin warned again

The US Food and Drug Administration raised concerns about Lupin Limited’s overall corporate quality system in an 11 June warning letter concerning the company’s Novel Laboratories Inc. facility in Somerset, NJ.

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