AGC Bi­o­log­ics hit with 483 for poor dis­crep­an­cy in­ves­ti­ga­tion prac­tices, qual­i­ty con­trol is­sues at Wash­ing­ton site

CD­MO ACG Bi­o­log­ics re­ceived an FDA 483 let­ter, pub­lished on the FDA web­site this week, not­ing one of its sites failed to con­duct prop­er in­ves­ti­ga­tions in­to dis­crep­an­cies, lack of qual­i­ty con­trol over man­u­fac­tur­ing and lack of as­sur­ance to pre­vent con­t­a­m­i­na­tion.

The 15-page let­ter was writ­ten af­ter a five-day in­spec­tion in Feb­ru­ary 2023 at a site in Both­ell, WA, which is de­signed for mam­malian and mi­cro­bial fer­men­ta­tion man­u­fac­tur­ing, process de­vel­op­ment and R&D.

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