A Pfizer manufacturing site for injectable drugs, Hospira Healthcare in Tamil Nadu, India, has received a 32-page Form 483 from the FDA.
A Pfizer manufacturing site for injectable drugs, Hospira Healthcare in Tamil Nadu, India, has received a 32-page Form 483 from the FDA, noting 11 inspection observations.
The citations identified several manufacturing and quality control issues with the plant, including the following:
Hospira, which was acquired by Pfizer in 2015, has been the subject of several 483s and FDA warning letters in manufacturing sites outside of India as well, specifically across the Americas, as well as in Italy. Additionally, according to Pfizer, Hospira has issued 11 nationwide recalls in the United States since 2010.
“We’re disappointed with the outcome of a recent regulatory inspection at our manufacturing facility. 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,” said Pfizer spokesperson Steve Danehy, in a recent interview. “Pfizer is committed to product quality and we have voluntarily paused production at our Irungattukottal, India site.”
In addition to its other products, Pfizer currently has 6 biosimilars in registration or phase 3 development, including an adalimumab referencing Humira, a bevacizumab referencing Avastin, an epoetin alfa referencing Epogen and Procrit, a filgrastim referencing Neupogen, a rituximab referencing Rituxan/MabThera, and a trastuzumab referencing Herceptin. However, the Hospira plant is not involved in the manufacturing of biosimilars.