FDA warns another Indian firm on data

FDA has issued a warning letter to India’s Sri Krishna Pharmaceuticals, citing data manipulation and failure to protect data integrity. Among its main products, Sri Krishna lists acetaminophen, folic acid, domperidone, and enalapril. During a December 2014 visit, FDA inspectors found that Sri Krishna technicians had deleted test results without explanation and fabricated sample test data. Moreover, technicians “routinely turned HPLC audit trails on and off,” FDA found. After the inspection, FDA communicated its concerns to Sri Krishna but eventually decided to issue a formal warning letter after finding the company’s response unsatisfactory.