The US regulator called for an investigation in a letter sent to Megafine last month, explaining that the firm’s response to an earlier Form 483 detailing evidence of stability data falsification was ‘inadequate.’
“In your response, you stated that laboratory management did not discover the discrepancy until the 24-month stability interval. You also stated that the batch quality is unaffected because subsequent test results met specifications at the 24-month and 36-month stability intervals.
“Your response is inadequate because it does not address the extent of the data falsification that could exist in your laboratory.
The agency added that: “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 U.S. distribution.”
Remediation
The US Food and Drug Administration (FDA) said Megafine needs to investigate extent of the inaccuracies in data records and reporting and ask a third party to interview current and former employees about data management practices.
The agency also said Megafine management need to put together a corrective action plan and provide details of measures that will prevent data falsification in the future.
The Nashik facility has been banned from supplying active pharmaceutical ingredients (APIs) since October last year when Megafine was placed on the agency’s import alert.
Megafine will remain on the list of firms banned from shipping APIs to the US until it complies with the FDA's request.
The firm, which still lists the Nashik facility as being accredited by the US FDA on its website, did not respond to a request for comment.