FDA Cites Another Company for Data Integrity Violations

June 1, 2016
BioPharm International Editors

FDA issues a warning letter to Megafine Pharma Limited for data integrity violations.

On May 19, 2016, FDA issued a warning letter to API manufacturer Megafine Pharma Limited, Mumbai, for deviations of current good manufacturing practices including data integrity violations. The warning letter follows an FDA inspection of the company’s Nashik facility in May 2015.

Specifically, FDA’s inspection of the facility found that the company had not ensured that appropriate laboratory tests were conducted for each batch of intermediate and API to determine conformance to specifications. FDA says in the letter that an employee falsified test data and “substituted a reference standard chromatogram in place of the 12-month stability interval chromatogram.” These data were then submitted to FDA in support of a drug master file (DMF).

The company responded to the observation saying the company did not discover the discrepancy until the 24-month stability interval. FDA, however, says the company’s response is inadequate “because it does not address the extent of the data falsification that could exist in your laboratory. You have not provided the results of any investigation to determine the accuracy of the test data for other batches of drugs and the corrective actions that should be implemented to ensure the quality of the drugs intended for US distribution.” FDA is, therefore, asking the company to conduct a complete review of all their data related to the DMF in question and provide the agency with an assessment of any discrepancies and a review of all test results for any distributed batches of the product. 

The 2015 FDA inspection also found that the company had not prevented unauthorized access or changes to data or provide controls to prevent manipulation or omission of data. According to the warning letter, company analysts deleted and manipulated data in order to make it appear that drugs were meeting specifications. FDA is asking the company “to provide the residual solvent results performed by an independent laboratory for all lots of drugs distributed to the United States.”

The company also failed to investigate critical deviations and batch failures properly. FDA is requesting the company have an independent laboratory perform impurity testing on products distributed in the US.

In general, FDA is asking the company to perform data integrity remediation and provide the agency with results from a comprehensive investigation into data records, a risk assessment of the potential effects of observed failures on the quality of the company’s products, and a management strategy for a global corrective action and preventive action plan.

Source: FDA