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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

Pfizer
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The Pfizer business includes two of the 10 top-selling consumer health care brands globally in Advil and the multivitamin line Centrum. Photo: reuters

Gireesh BabuAneesh Phadnis Chennai | Mumbai
Pfizer's manufacturing facility in Tamil Nadu’s Sriperumbudur 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 Hospira Healthcare India in Sriperumbudur conducted in last March-April.

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

A Pfizer spokesperson said they were disappointed with the outcome of the drug regulator’s inspection. “We have submitted a comprehensive response to the USFDA