FDA 483 - Vimta Labs Limited - December 18, 2019

Vimta Labs Ltd. in Hyderabad, India, a GLP Laboratory, was inspected by the FDA and received 11 observations. The inspection revealed significant deficiencies in personnel training, protocol adherence, facility design, test article control, SOP establishment, data integrity, and final report completeness. These issues indicate a systemic failure to maintain adequate Good Laboratory Practice standards.