The U.S. Food and Drug Administration has issued a warning letter to Indian contract research organisation Semler Research about misconduct and violations of federal regulations including data integrity issues at its facility in Bengaluru.
The FDA has notified the companies that have filed for drug approval based on the data provided by Semler that these studies are not acceptable as a result of data integrity concerns and need to be repeated.
FDA said it was taking this action as a result of an inspection of Semler’s bioanalytical facility in Bengaluru, conducted between September 29 and October 9, 2015.
“The inspection found significant instances of misconduct and violations of federal regulations, including the substitution and manipulation of study subject samples,” FDA said in a statement.
Semler said it is in the process of reviewing the concerns raised by the agency. The firm said it has engaged a high quality consulting firm to review the data and would be providing a detailed response to these concerns.
“We understand the seriousness of this notification,” said a Semler spokesperson said in an email response.
