FDA whacks Megafine India API plant with warning for faked test data


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.


Survey: The Critical Role of Innovation in Launching Successful OTC Products

This research aims to understand the importance of product innovation and dose forms in driving new product design and development, consumer engagement and purchase interest for Over-the-Counter medicines. The first 50 qualified respondents will receive a $5 Amazon gift card. Take the survey now.

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

Related Articles: 
FDA bans API plant of India's Megafine Pharma 
FDA castigates India's Emcure for routinely faking data 
FDA nails Sun plant for same data deletions found at Ranbaxy 
FDA warning letter lays out issues at banned Wockhardt plants

Suggested Articles

Neopharma, which has been buying and building plants for several years, is buying a sterile injectables plant and assets in Japan from India’s Lupin. 

Already knocked by the FDA four times this year, Dr. Reddy’s now has a fifth Form 483 to dwell on. This time it’s at a plant with a history of faults.

In a warning letter, the FDA details how a Chinese OTC drugmaker handed over documents faked just for the agency's inspection—and admitted it.