Faking data has won another Indian drugmaker a stern warning from the FDA. This time it is a Megafine Pharma plant whose products the FDA banned last year for the kind of data integrity shenanigans that inspectors have found repeatedly at Indian drug and API plants, indicating that some companies refuse to change until they get caught.
The letter was issued to Megafine on May 19, about a year after inspectors uncovered a list of data problems at the API plant in Village Lakhmapur in Nashik, including a confession from an analyst that stability testing data had been falsified.
The FDA slapped down Megafine’s earlier response to the Form 483 issued in May 2015 and told Megafine it needs to bring in an outside auditor who can get to the bottom of the company’s data integrity issues and help management put together a global plan to make sure they stop.
In that response, Megafine tried to convince the FDA that the falsified stability data didn’t really matter because the batch quality was confirmed by tests at the 24-month interval. But the FDA said that was not good enough because that was one batch. Megafine, the FDA said, needs to find out how many other batches had faked tests and whether they may be compromised.
The FDA keeps finding these kinds of problems at Indian manufacturers big and small. Companies like Sun Pharmaceutical and Ranbaxy Laboratories, now owned by Sun, have been cited for faking data, as have plants operated by Apotex, Emcure and many others. Currently, more than 40 Indian manufacturing facilities are on the FDA import alert lists, many of them for data integrity issues.
- read the warning letter
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