The US health regulator has issued a warning letter to Mumbai-based Megafine Pharma for violations of good manufacturing norms, including data falsification and failure to prevent data manipulation at the company’s Nashik plant.
Summarising significant deviations from CGMP (current good manufacturing practice) norms at the Nashik facility, the US Food and Drug Administration (USFDA) said that its investigator observed several significant deviations.
In the letter to company’s director Hasmukh Gandhi, FDA said one of the company’s analysts acknowledged falsifying test data and “substituted a reference standard chromatogram in place of the 12-month stability interval chromatogram”.
While the company had responded that its laboratory management did not discover the discrepancy until the 24-month stability interval and the batch quality was unaffected, the USFDA said the reply was inadequate as it did not address the extent of the data falsification that could exist in its laboratory.
The USFDA further said one of the deviations was “failure to ensure that, for each batch of intermediate and API, appropriate laboratory tests are conducted to determine conformance to specifications.”
Another major violation of the current good manufacturing practice (CGMP) norms was the failure to prevent unauthorised access or changes to data and to provide adequate controls to prevent manipulation and omission of data, it added.
Raising data integrity remediation issue, the letter said the quality system of Megafine Pharma “does not adequately ensure the adequacy and integrity of data to support the safety, effectiveness, and quality of drugs you manufacture”.
It also pulled up the company for conducting “inadequate investigation of critical deviations or a failure of a batch to meet its specifications or quality standards”.
It asked the company to do a comprehensive investigation into the extent of the inaccuracies in data records and reporting.
The US health regulator said until the company corrected all the deviations and the compliance with CGMP is confirmed by it, USFDA “may withhold approval of any new applications or supplements listing your firm as an API manufacturer.”
Failure to correct these violations may also result in the USFDA continuing to refuse admission of articles manufactured at Megafine Pharma’s Nashik plant, it added.