The US Food and Drug Administration (FDA) set out its concerns in a warning letter last week detailing batch testing and documentation problems identified at Vital’s plant II in Vapi, Gujarat during an audit conducted in April.
The agency said issues at Vapi – the failure to test active pharmaceutical ingredients and the failure to document each stage of production – are similar to deficiencies seen at Vital’s Plant I facility during an inspection in 2015.
It said: “These repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate” adding that Vital’s management team are responsible for addressing the issues.
“Your executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance.
“You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems, processes, and ultimately, manufactured products, conform to FDA requirements” the FDA wrote.