In a 32-page US Food and Drug Administration (FDA) Form 483, 11 citations revealed manufacturing and quality control issues at the Hospira Healthcare India facility in Tamil Nadu.
FDA visited the manufacturing facility over the course of six days from March through early April and found seven nonconformities relating to the firm’s laboratory system. These ranged from unreliable microbiology laboratory data and manipulated test sample weights to a lack of stability-indicating methods for finished pharmaceutical products.
The citations add on to the troubles that Hospira—acquired by Pfizer
in 2015—has been facing at its Indian facility since at least 2011, though only three were repeat observations this time.
“We’re disappointed with the outcome of a recent regulatory inspection at our manufacturing facility,” Pfizer spokesperson Steven Danehy told Focus
. “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. Pfizer is committed to product quality and we have voluntarily paused production at our Irungattukottal, India site.”
Repeat observations from a November 2016 site visit include a failure to complete investigations within a “desirable time period” and ensure that “all production and laboratory control operations are compliant with good manufacturing practices (GMP),” the 483 states. These relate to the drug manufacturer’s quality control unit and quality assurance department.
A repeated citation explains why the firm’s processes for conducting investigations into customer complaints were deemed deficient. For example, the firm had not decided on an action for an investigation into 12 injection batches at the time of FDA’s visit, despite having discovered that these had yielded out-of-specification results 12 months prior.
According to the 483, seven out of the 12 affected batches have already expired since the investigation was opened last November.
The lengthiest inspectional observation cites issues with Hospira’s production system, such as a lack of process assessments to prevent recurrence of quality defects with filled vials.
FDA also cited Hospira over a lack of procedures to prevent products from microbiological contamination in five different 483s, including the latest one, which was issued in April but posted on the agency’s website on Wednesday. The first time this issue was cited was in 2011.
The Hospira manufacturing facility in Sriperumbudur, India has drawn not just several
483s, but also at least one FDA warning letter
—issued in May 2013.
Significant GMP violations have also been flagged in FDA warning letters at Hospira drug manufacturing sites across the Americas
, including its Kansas
site in 2017, and Italy
Pfizer’s website also shows Hospira has issued 11 nationwide recalls
in the US since 2010.
Hospira Healthcare India FDA Form 483