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.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.