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Cadila receives FDA warning letter for GMP violations

India-based drug developer Cadila Healthcare has received warning from the US Food and Drug Administration (FDA) for violating good manufacturing practices (GMP) at its manufacturing plant located at Sarkhej Bavla N.H. No.8 A, Moraiya, Tal: Sanand, Dist. Ahmedabad, Gujarat, India.

The FDA’s decision was based on its inspection which it has conducted in February 2011 and identified significant violation of current good manufacturing practices at the plant, reported www.wsj.com.

The FDA has said the corrective measures taken by the Zydus Group was not sufficient enough to influence the regulators in a positive way.

The US regulators have further asked the Indian firm to take major steps for resolving the issues within 15 days of receiving the warning letter.