Up­dat­ed: Con­t­a­m­i­na­tion is­sues lead to FDA warn­ing let­ter for South Car­oli­na man­u­fac­tur­ing fa­cil­i­ty

A con­tract man­u­fac­tur­ing fa­cil­i­ty in South Car­oli­na that makes a saline so­lu­tion to help re­plen­ish lost wa­ter and salt has been giv­en a warn­ing let­ter from the FDA over sev­er­al is­sues re­lat­ed to cross-con­t­a­m­i­na­tion and oth­er qual­i­ty is­sues.

An in­spec­tion ear­li­er this year not­ed that the site had found cross-con­t­a­m­i­na­tion of drugs in at least “three lots of drug prod­ucts,” with Nephron not prop­er­ly in­ves­ti­gat­ing why this hap­pened. The warn­ing let­ter, which was is­sued on Oct. 11, was sent to con­tract man­u­fac­tur­er Nephron over is­sues not­ed at its fa­cil­i­ty in West Co­lum­bia, SC.

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