Granules 483-hit API plant receives all clear from US FDA

By Dan Stanton

- Last updated on GMT

Image: iStock/boygovideo
Image: iStock/boygovideo

Related tags Food and drug administration Pharmaceutical drug Fda

A Granules API plant in Hyderabad which received a Form 483 with three observations has been given the all clear by the US FDA.

The US Food and Drug Administration (FDA) has issued an Establishment Inspection Report (EIR) to the Jeedimetla facility in Hyderabad, India, ending concerns over quality and safety observed during an inspection in December last year.

We have responded to US FDA within stipulated time and they have acknowledged our replies and closed it with issuance of EIR report,”​ Granules India spokesperson Sumanta Bajpayee told

“There were three observations and none of them were related to data integrity issue​,” Bajpayee added.

A number of FDA Warning Letters have been issued citing GMP violations referring to deficiencies in data integrity over the past few years, with Indian API and drugmakers receiving the lion’s share (see here​, here​ and here​, for example), and the Agency has recently issued draft guidance​ to address the problem.

The Jeedimetla plant manufactures active pharmaceutical ingredients (APIs) for type 2 diabetes drug metformin, the OTC expectorant guaifenesin and the muscle relaxant methocarbamol.

Claris all clear

The US FDA has also sent an EIR to Claris Lifesciences’ manufacturing facility near Ahmedabad, concluding that the inspection stands closed and the facility was found to be acceptable.

“The US FDA had conducted audit at Claris’ manufacturing facility in May 2015,”​ the firm said in a filing with the Bombay Stock Exchange. “The company had taken appropriate steps to address the observations it had received from these audits.”

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