Cadila gets five observations from US FDA

Cadila Healthcare said the US health regulator has issued five observations after inspection of its subsidiary Liva Pharmaceuticals’ injectables manufacturing facility. "This was a product specific pre-approval inspection. It concluded with five observations. Liva will respond to US FDA within 15 days. It may be noted that at present Liva does not export any products to the US market," Cadila Healthcare said in a filing to BSE.

The injectables facility is located at Vadodara. United States Food and Drug Administration (US FDA) conducted the inspection from August 20-28. Liva is a 100 per cent subsidiary of Cadila Healthcare.

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