NEW DELHI: The US health regulator has issued a warning letter to Mumbai-based Megafine Pharma for violations of good manufacturing norms at its VapiBSE 4.92 % facility in Gujarat.
Summarising significant deviations from CGMP (current good manufacturing practice) norms at the Vapi unit, the US Food and Drug Administration (USFDA) said that its investigators observed several lapses.
In the letter to the company’s Business Development Director Shailesh Sanghvi, USFDA said, “Our investigators found that you sourced material from a facility on FDA Import Alert 66-40 for failure to meet CGMP requirements.”
The plant manufactures active pharmaceutical ingredient (API) intermediates. The firm’s quality unit approved the use of adulterated materials to manufacture drugs, it added.
The FDA termed the response of the company as inadequate.
The other issue flagged by the regulator was “failure to establish and follow adequate written procedures for cleaning equipment and its release for use in API manufacture, and to maintain adequate records of major equipment usage.”
Response by the company failed to address the adequacy of preventive maintenance to ensure that the equipment is in a good state of repair and will not contaminate drugs with material accumulated on surfaces that come in contact with its drugs, FDA said.
The USFDA further said that “your test methods were not capable of demonstrating the purity of your drugs.”
Another major violation of CGMP norms was that the company’s quality system did not adequately ensure the accuracy and integrity of data to support the safety, effectiveness and quality of the drugs it manufactures, FDA said.
“Until you correct all deviations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer,” the letter said.
Failure to correct these violations may also result in the USFDA continuing to refuse admission of articles manufactured at Megafine Pharma’s Vapi plant, it added.