FDA cites litany of errors at Lonza Houston plant at the center of Bristol Myers CVR debacle
Investors’ somewhat longshot bet on a $9 CVR tied to Bristol Myers Squibb’s acquisition of Celgene came to a screeching halt last month after the FDA took too long to decide on CAR-T candidate liso-cel. One of the potential culprits in that delay, a December inspection of a contract manufacturer, now appears to have played a big role after the FDA cited a number of issues at that plant.
In a Form 483 published online this week, the FDA blasted Lonza Houston, one of the contract manufacturers for liso-cel, for a litany of errors, including mislabeling, products for the US and EU drug markets stored in the same bins, “poorly maintained” freezer units, and expired batches of ingredients that weren’t properly disposed of.
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