Ip­ca Lab­o­ra­to­ries cit­ed for qual­i­ty is­sues at In­dia fa­cil­i­ty that pro­duces API

The FDA iden­ti­fied sev­er­al qual­i­ty is­sues at a plant in In­dia owned by Ip­ca Lab­o­ra­to­ries that makes ac­tive phar­ma­ceu­ti­cal in­gre­di­ents.

In the sev­en-page in­spec­tion re­port, the FDA cit­ed sev­er­al is­sues dur­ing an in­spec­tion at a fa­cil­i­ty in Pi­paria, In­dia, that took place be­tween April 18 to 26.

The in­spec­tion found that the site had not prop­er­ly in­ves­ti­gat­ed sev­er­al batch­es of prod­ucts, shared re­sults with­out get­ting to the root of is­sues in some cas­es, and had not prop­er­ly fol­lowed the in­ves­ti­ga­tion­al pro­ce­dure in oth­er cas­es.

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