FDA 483 - Panexcell Clinical Lab PVT. LTD. - January 19, 2018

Panexcell Clinical Lab (P) LTD., a Clinical Research Organization in Navi Mumbai, India, was inspected by the FDA. The inspection revealed that an adequate final report was not provided to the sponsor shortly after the completion of an investigator's participation in a study. Specifically, incorrect adverse event onset dates were reported in a clinical study report for an ANDA study.