FDA 483 - Vimta Labs, Limited - August 16, 2019

An FDA inspection of Vimta Labs Ltd. in Hyderabad, India, revealed a significant failure to maintain adequate case histories for subjects enrolled in two bioequivalence studies. The firm did not ensure that all subjects had readable chest X-rays, a critical requirement specified in their ethics committee-approved protocols. This indicates a serious deficiency in data integrity and adherence to study protocols.