Am­neal Phar­ma­ceu­ti­cals site in In­dia re­ceives 483 over clean­ing and oth­er qual­i­ty is­sues

A man­u­fac­tur­ing site that be­longs to Am­neal Phar­ma­ceu­ti­cals is un­der the FDA’s mi­cro­scope.

The site in ques­tion is a par­enter­al, or in­jectable, man­u­fac­tur­ing fa­cil­i­ty in the city of Ahmed­abad, In­dia, lo­cat­ed in the west­ern state of Gu­jarat. The site was in­spect­ed be­tween Dec. 13 and Dec. 23 of last year. The nine-page in­spec­tion re­port had 15 ob­ser­va­tions not­ed by the FDA.

The in­spec­tion stat­ed that em­ploy­ees who are a part of the asep­tic pro­cess­ing of a drug prod­uct usu­al­ly wear pro­tec­tive eye­wear, but four em­ploy­ees were ob­served not ap­pro­pri­ate­ly wear­ing gog­gles in one asep­tic area. An­oth­er area where asep­tic op­er­a­tions took place was ob­served to be too small for em­ploy­ees to per­form their tasks.

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