Up­dat­ed: FDA slaps Op­tum In­fu­sion with a warn­ing let­ter over 'in­san­i­tary' pro­duc­tion con­di­tions

The FDA is­sued a warn­ing let­ter to Op­tum In­fu­sion Ser­vices last month cit­ing a list of po­ten­tial con­t­a­m­i­na­tion con­cerns, in­clud­ing “ver­min” found in a pro­duc­tion area.

The let­ter, post­ed by the FDA on Tues­day, ac­cus­es Op­tum of pro­duc­ing ster­ile drug prod­ucts “un­der in­san­i­tary con­di­tions.” It fol­lows a Form 483 filed back in March up­on in­spec­tion of the com­pa­ny’s Chan­dler, AZ, site.

An in­ves­ti­ga­tor re­port­ed that Op­tum failed to “per­form ad­e­quate prod­uct eval­u­a­tion and take ap­pro­pri­ate cor­rec­tive ac­tion af­ter ver­min was ob­served in your pro­duc­tion area,” and af­ter “mi­cro­bial con­t­a­m­i­na­tion was re­cov­ered” in an asep­tic pro­cess­ing area.

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Recon Strategy

Boston, MA, USA