FDA 483 - Lotus Labs Pvt. Ltd. - August 22, 2017

From August 16 to 22, 2017, the U.S. Food and Drug Administration (FDA) conducted an inspection of Lotus Labs Private Limited, a contract research organization located in Bangalore, India. The inspection focused on the firm"s clinical trial operations and resulted in several significant observations regarding participant safety and protocol adherence. Primary violations included the performance of invasive screening procedures, such as blood and lung function tests, without first obtaining informed consent from participants. Furthermore, the consent documents provided to participants were found to be deficient, lacking essential information regarding risks, benefits, and the voluntary nature of the research. The FDA investigators also identified failures in safety monitoring, noting that the firm stopped tracking a serious injury before it had fully resolved. Additionally, the firm was found to have enrolled participants who should have been excluded from studies due to abnormal laboratory results that violated specific trial protocols. These findings were issued under the Federal Food, Drug, and Cosmetic Act. While this report does not represent a final legal determination, Lotus Labs is required to respond to these observations. The firm must outline its planned corrective actions to address these systemic failures in clinical oversight and ensure future compliance with safety standards.