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.
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 and are committed to implementing the necessary improvements and ensuring the quality of our medicines. Pfizer is committed to product quality and we have voluntarily paused production at our Irungattukottai site.”
The facility had earlier received observations from the USFDA as part of inspections in 2013 and 2015, according to reports.