FDA 483 - Daicel Chiral Technologies (India) Private Limited - February 10, 2016

An FDA inspection of Daicel Chiral Technologies (India) Private Limited, a control testing laboratory, revealed deficiencies in employee training and attendance record-keeping. Specifically, employees signed training logs for dates they were not present, and attendance registers showed unauthorized alterations. Additionally, GMP training was not conducted with sufficient frequency to ensure ongoing compliance.