Con­tract man­u­fac­tur­er: FDA has halt­ed do­mes­tic phar­ma in­spec­tions

The FDA ap­pears to have halt­ed its do­mes­tic in­spec­tions of phar­ma­ceu­ti­cal fa­cil­i­ties, al­though not be­fore at­tempt­ing to in­spect a con­tract de­vel­op­ment and man­u­fac­tur­ing or­ga­ni­za­tion (CD­MO) on Mon­day and sub­se­quent­ly de­cid­ing to end the in­spec­tion ear­ly and an­nounce the halt.

The CEO of the CD­MO, who re­quest­ed that he and his firm re­main anony­mous, ex­plained to Fo­cus via email how his com­pa­ny re­ceived a last-minute in­spec­tion re­quest from an FDA in­spec­tor whose planned trip for in­spec­tions in Eu­rope was can­celed.

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