Room tem­per­a­ture ther­a­pies and bi­o­log­ics stored with lunch: New York drug im­porter hand­ed FDA warn­ing let­ter

A drug man­u­fac­tur­ing fa­cil­i­ty on Long Is­land was hand­ed a warn­ing let­ter by the FDA last month af­ter in­spec­tors found the com­pa­ny stored chemother­a­py drugs and hu­man preg­nan­cy hor­mones at room tem­per­a­ture and phar­ma­ceu­ti­cal in­gre­di­ents in the same room as weed killer.

Syn­tec Phar­ma will now have to come up with a suf­fi­cient game plan to pre­vent cross-con­t­a­m­i­na­tion be­tween phar­ma­ceu­ti­cals and oth­er prod­ucts, as an im­port alert has been placed on all prod­ucts from three ac­tive in­gre­di­ent sup­pli­ers.

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.