Man­u­fac­tur­ing roundup: Hik­ma, Lil­ly US man­u­fac­tur­ing sites hit with 483s; GAO says HHS should ad­dress stock­pile risks

The FDA has hand­ed down in­spec­tion re­ports to sev­er­al man­u­fac­tur­ing sites in New Jer­sey, re­veal­ing a range of qual­i­ty con­trol is­sues.

The 483 in­spec­tion re­port for Hik­ma In­jecta­bles’ out­sourc­ing fa­cil­i­ty in Day­ton, NJ, notes three ob­ser­va­tion­ss from an in­spec­tion from late May to ear­ly June of this year.

The in­spec­tion re­veals that the “air­borne par­tic­u­late mon­i­tor­ing pro­gram for asep­tic op­er­a­tions” was not de­signed to sup­port the qual­i­ty of drug prod­ucts meant to be ster­ile and was not mon­i­tor­ing air­borne par­tic­u­lates cor­rect­ly. The FDA not­ed on mul­ti­ple oc­ca­sions that “par­ti­cle Coun­ters” were not be­ing di­rect­ed in­to the flow of air.

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