Data manipulation and integrity issues have struck again as the FDA called out India's Sri Krishna Pharmaceuticals in a newly published warning letter, highlighting several concerns it's noted for years at the drugmaker's operation.
The Hyderabad-based company's manufacturing shortfalls include incomplete data, a lack of computer system controls to ensure quality data and a lack of documented procedures to guarantee drug quality, the letter said. During the plant inspection, staff were found in multiple instances deleting data and one quality-control employee “admitted plans to fabricate sample preparation data,” the FDA’s letter said.
Sri Krishna Pharmaceuticals, which Reuters reports supplies acetaminophen and other drugs to more than 60 countries worldwide, has been on the FDA’s radar for quite a while--the regulator said it found “similar issues” there back in 2007.
Now, though, the Indian drugmaker joins a host of its peers who have drawn the FDA’s ire for shoddy manufacturing systems. In recent months and years, the FDA and regulators in Europe have stepped up inspections and levied punishments for companies such as Wockhardt, Sun Pharma, Ranbaxy Labs and others. In many cases, recurring problems such as data manipulation and the potential for contamination have been found.
The FDA isn't alone in raising the alarm for the practices at Sri Krishna's plant. Last year, the Italian Medicines Agency recommended products from the facility be banned following an inspection that turned up 10 “major” issues. Inspectors found that employees were backdating testing equipment and changing test results repeatedly until arriving at an acceptable result. As Reuters notes, the FDA’s letter follows Canada’s move a year ago to block Sri Krishna imports based on data worries.
Though the Sri Krishna findings stem from an inspection more than a year ago, the FDA says the company’s response on December 24, 2014, “lacks sufficient corrective actions.” The FDA asked for a response from Sri Krishna detailing the company’s plan to fix the shortfalls.
Pictured is the Hyderabad financial district, courtesy of Wikipedia user Yedla70.