Brigham and Wom­en's gets FDA warn­ing let­ter af­ter PET op­er­a­tion vi­o­la­tions

A drug man­u­fac­tur­ing fa­cil­i­ty at one of Boston’s top hos­pi­tals has re­ceived a warn­ing let­ter from the FDA af­ter its man­u­fac­tur­ing prac­tices for positron emis­sion to­mog­ra­phy drugs were not found to be up to reg­u­la­to­ry code.

The FDA ad­dressed Brigham and Women’s Hos­pi­tal in a let­ter dat­ed April 11. The let­ter is ad­dressed to Sunil Eap­pen, the in­ter­im pres­i­dent and CMO at the hos­pi­tal.

Fa­cil­i­ties were not ad­e­quate­ly pre­pared to pre­vent the con­t­a­m­i­na­tion that could lead to side ef­fects in the prod­ucts, the let­ter said. The hos­pi­tal al­so did not en­sure that the equip­ment is suit­able for asep­tic op­er­a­tions. “Wa­ter in­fil­tra­tions” that oc­curred be­tween Ju­ly and Oc­to­ber 2020 were in close prox­im­i­ty to equip­ment used in the PET asep­tic pro­duc­tion op­er­a­tion, in­clud­ing hot cells, bi­o­log­i­cal safe­ty cab­i­net, and the lam­i­nar flow hood. An over­head wa­ter pipe was ac­tive­ly leak­ing on­to the floor in the same room in which raw ma­te­ri­als were stored too, and there were fun­gal species found in the ISO 5 clas­si­fied cells.

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