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Pfizer stops production at Tamil Nadu plant after 11 USFDA observations

Firm says it is disappointed with the outcome of the inspection

Gireesh Babu & Aneesh Phadnis  |  Chennai | Mumbai 

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Pfizer's manufacturing facility in Tamil Nadu’s is not following quality control norms and lacks data related to laboratory records. These are among the 11 observations the US Food and Drug Administration (USFDA) has made following inspections at the India in conducted in last March-April.

The company said it had “voluntarily paused” production in the facility, which became a part of following its acquisition of US-based in February 2015 in a $17-billion deal.

A spokesperson said they were disappointed with the outcome of the drug regulator’s inspection. “We have submitted a comprehensive response to the and are committed to implementing the necessary improvements and ensuring the quality of our medicines. is committed to product quality and we have voluntarily paused production at our Irungattukottai site.”

The facility had earlier received observations from the as part of inspections in 2013 and 2015, according to reports.

First Published: Fri, July 13 2018. 02:11 IST
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