FDA warns Mex­i­can glyc­erin man­u­fac­tur­er for re­fus­ing an in­spec­tion

A drug man­u­fac­tur­ing fa­cil­i­ty in Mex­i­co is draw­ing the ire of the FDA af­ter it ig­nored the US reg­u­la­tor’s in­spec­tion re­quests and phone calls.

Ac­cord­ing to the warn­ing let­ter is­sued on June 13, Gliceri­nas In­dus­tri­ales re­fused a pre-an­nounced in­spec­tion dur­ing a phone call with FDA pri­or to the in­spec­tion at the com­pa­ny’s fa­cil­i­ty in Za­popan, Mex­i­co, a city next to Guadala­jara, which was planned for May 16 to May 20.

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