FDA 483 - Vimta Labs Limited - October 26, 2018

Vimta Labs Ltd. in Hyderabad, India, a GLP Laboratory, was cited with five observations during an FDA inspection from October 22-26, 2018. The inspection revealed significant issues including inadequate environmental control equipment and monitoring, insufficient training and qualification of study personnel, and failures in documenting SOP deviations. Additionally, the quality assurance unit did not adequately inspect studies or maintain proper records, and critical raw data and documentation were not retained.