The US health regulator has issued a warning letter to Mumbai-basedMegafine Pharma for violations of good manufacturing norms at its Vapi facility in Gujarat.
Summarising significant deviations fromCGMP (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."