FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

India’s Ipca Labs Receives Warning Notice from FDA for Systemic Data Manipulation

Feb. 17, 2016

The FDA has slammed yet another Indian drugmaker for data integrity issues. This time it rebuked Ipca Laboratories for data falsification at three of the company’s manufacturing facilities.

During a July 2014 inspection at the company’s Ratlam API facility in Madhya Pradesh, inspectors determined that someone had deleted original data for test samples and back dated test data. In addition, computerized systems lacked sufficient controls to prevent unauthorized access or changes to data.

“These practices appear to be commonplace in your analytical laboratory,” the warning letter chides, adding that during the inspection an analyst told inspectors, “‘if we find a failure, we set back the date/time setting and re-integrate to achieve passing results.’” The analyst noted that “deleting, overwriting, changing integration parameters, and altering PC date and time settings were done for raw materials, in-process testing and finished API drugs.”

The warning letter references an anonymous email dated Aug. 5, 2013 that notified quality management about data falsification and manipulation in the laboratory and cited the company for failing to do anything about it.