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US FDA says insufficient corrective action at Sun Pharma’s API plant

LiveMint logoLiveMint 20-05-2014 C.H. Unnikrishnan

Mumbai: Sun Pharmaceutical Industries Ltd has not taken sufficient corrective action at its bulk drugs factory in Gujarat to comply with quality manufacturing rules, the US Food and Drug Administration (FDA) said.

“We have conducted a detailed review of your firm’s initial response and note that it lacks sufficient corrective actions,” FDA said in a 7 May letter posted on Tuesday.

The FDA in March banned imports from the Karkhadi plant near Vadodara after observing violations in quality norms during an inspection in November. Sun Pharma had responded to the FDA’s observations in two letters.

Sun Pharma could not be immediately reached for comments.

The US regulator has noticed in the plant a failure to ensure that laboratory records included complete data derived from all production tests necessary to ensure compliance with established specifications and standards, the FDA said in the letter.

“These analyses lack the critical data including identification of the samples tested, the complete record of all raw data generated during each test, test method used, sample preparation as prescribed by the method, preparation and testing of standards, reagents and standard solutions among others,” said the FDA letter addressed to Sun Pharma chief executive officer Subramanian Kalyanasundaram.

“The Karkhadi factory that makes a small quantity of antibiotics contributes a negligible part to Sun Pharma’s consolidated revenue,” the firm had said in March.

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