Sun Pharma Says USFDA Made 9 Observations at Halol Unit


Sun Pharma said that none of the observations were repeat observations, which eases concerns over an import alert from the US FDA for the plant

Mumbai: Sun Pharmaceutical Industries Ltd said on Thursday the US Food and Drug Administration (US FDA) has made nine observations relating to deviations from good manufacturing practices at its Halol plant in Gujarat, following an inspection between 17 November and 1 December.

On Wednesday, the company had said the Halol plant got a Form 483 from the US FDA but did not give details on the number and nature of the observations.

ALSO READ : Sun Pharma Gets Another FDA Notice; Form 483 Issued Against Halol Facility 

“At the conclusion of the inspection, the USFDA issued a Form-483, citing nine inspectional observations. None of those observations were characterised by the USFDA as repeat observations,” it added.

However, the company did not disclose the observations made by the USFDA.

“The company has said that none of them were repeat observations, which eases concerns over an import alert from the US FDA for the plant,” an analyst, who did not wish to be named, said.

Sun Pharma said is preparing its responses to the fresh observations, which will be submitted to the US drug regulator within the stipulated time, and plans to promptly implement corrective actions at the Halol unit that may be necessary to address the issues mentioned in the observations.

ALSO READ : Sun Pharma’s Mohali Unit Violated Manufacturing Norms, Finds USFDA

Sun Pharma was earlier issued a warning letter by the USFDA for its Halol facility in December 2015. The letter followed inspection of the facility in September 2014 by FDA inspectors.

The company has been making efforts to make the Halol plant CGMP-compliant again.

As per the USFDA, observations are made in Form 483 when investigators feel that conditions or practices in the facility are such that products may become adulterated or render injuries to health.

The FDA Form 483 notifies the company’s management of objectionable conditions.

On Thursday, shares of Sun Pharma ended up 1.75% at Rs675.55 on the BSE after falling 6% on Wednesday. The benchmark Sensex index, meanwhile, closed 1.74% up at 26,694.28 points.


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