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FDA Warns Lupin To Stop Blaming Lab And Fix Manufacturing Processes

 
• By Bowman Cox

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.

Warning Rubber Stamp

Lupin Ltd. should study whether excessive in-process hold times are responsible for out-of-specification results the Mumbai, India, firm has been routinely dismissing as outliers or results of laboratory error, US FDA says in a Nov. 6 warning letter that the agency published Nov. 15.

FDA also told Lupin that while it studies whether hold times are the culprit, it should go ahead and work to

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Potency Assay Issues Delayed US FDA Approval Of Mesoblast’s Ryoncil For Years

 
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Mesoblast’s Ryoncil: US FDA Changed Its Mind On Need For A Randomized Trial

 
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Ryoncil Chronology: Three Review Cycles, Two CRLs, One Dispute Resolution Request

 
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The Pink Sheet’s Drug Review Profile looks at the timeline for the clinical development and US FDA review of Mesoblast’s remestemcel for graft-versus-host disease.

More from Product Reviews

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PharmaMar Seeks EU Fast-Track Status For ‘Practice-Changing’ ES-SCLC Therapy

 
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