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.
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...
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