FDA in­spec­tion at Lupin man­u­fac­tur­ing site un­cov­ers break­downs left un­in­ves­ti­gat­ed and da­ta ques­tions

A March FDA in­spec­tion at Lupin’s man­u­fac­tur­ing site in Pi­tham­pur, In­dia has un­cov­ered qual­i­ty and oth­er per­for­mance is­sues.

The FDA’s 13-page 483 in­spec­tion re­port de­tailed the site’s fail­ure to doc­u­ment de­vi­a­tions or equip­ment fail­ures that oc­curred dur­ing man­u­fac­tur­ing and pack­ag­ing. Lupin had not done in­ves­ti­ga­tions, risk as­sess­ments or tak­en any pre­ven­ta­tive ac­tions for the break­downs, the re­port said.

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