- The Food and Drug Administration has warned Mumbai, India-based Megafine Pharma over several serious manufacturing violations which prompted the FDA to place Megafine on its import ban list last fall, documents recently posted on the FDA website show.
- A May inspection led to an admission by an employee to falsifying test data for stability batches, and found further evidence of data manipulation by multiple other analysts.
- Megafine, an API supplier, will be required to conduct a comprehensive investigation and risk assessment of the violations' potential effect on drug quality. The FDA recommended Megafine hire a third party to adequately investigate and conduct interviews of current and former employees.
The warning letter to Megafine is already the fifth such warning to Indian API manufacturers so far this year. Ipca Labs, Emcure Pharma, Sri Krishna Pharma, and Polydrug Labs have all already been censured by the FDA. Concerns over quality control and data integrity at Indian facilities has prompted increased oversight and scrutiny in recent years.
During the FDA's May inspection of Megafine's Nashik facility, an analyst admitted to falsifying stability test data in 2012. Although Megafine claimed batch quality was unaffected, the FDA found Megafine's response to be inadequate "because it does not address the extent of the data falsification that could exist in your laboratory."
And the admission to data manipulation in 2012 was not the only violation. "Multiple analysts, testing multiple drugs, deleted unknown peaks without justification. These manipulations made the drugs appear to meet their specifications," the FDA said.
The inspection's findings led the FDA to place Megafine on its import ban list in October of last year.
In response to these and other violations, Megafine will be required to conduct a comprehensive investigation, including interviews with current and former employees. The FDA suggested Megafine hire a third party to conduct the interviews along with a retrospective evaluation of all data integrity deficiencies.
Until such a review is completed, the FDA will continue to turn away any products Megafine attempts to ship to the U.S.