The US Food and Drug Administration (FDA) has issued Hospira Healthcare India a Form 483, following the inspection of its facility in Tamil Nadu, India, between March 27 and April 3 this year.
According to the FDA, inspectors observed 11 good manufacturing practice (GMP) violations, including inadequate production and laboratory control operations, and unreliable microbiology laboratory data.
Pfizer – which acquired Hospira in 2015 – said it was “disappointed” with the outcome of the FDA inspection.
“Pfizer is committed to product quality and we have voluntarily paused production at our Irungattukottai, India site until our internal review and remediation process are complete.
“We have submitted a comprehensive response to the FDA and are committed to implementing the necessary improvements and to ensuring the quality of our medicines,” we were told.
Hospira has attracted regulatory concern over manufacturing standards in the US for more than a decade. The FDA has issued a number of warning letters to the company during this time, including in 2010 in Rocky Mount, North Carolina, 2014 in Australia, and 2015 in Italy, as well as Form 483s – such as in Illinois in 2013, and India in 2014.