Eye drop producer KC Pharmaceuticals receives FDA warning letter

The FDA sent a warn­ing let­ter to Cal­i­for­nia-based eye drop man­u­fac­tur­er KC Phar­ma­ceu­ti­cals cit­ing sev­er­al is­sues re­lat­ed to the com­pa­ny’s qual­i­ty sys­tem.

In the warn­ing let­ter is­sued at the be­gin­ning of Au­gust, reg­u­la­tors said KC didn’t prop­er­ly per­form smoke stud­ies for its asep­tic pro­cess­ing lines or in­ves­ti­gate and suf­fi­cient­ly ad­dress me­dia fill fail­ures on its fill­ing lines. It al­so not­ed that KC’s “asep­tic pro­cess­ing op­er­a­tion is in­ad­e­quate­ly de­signed to pre­vent con­t­a­m­i­na­tion of your oph­thalmic drug prod­ucts.”

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