In the last 6 years, Pfizer’s Hospira plant in Kansas has received eight FDA Form 483 citations, as well as other observations for regulatory bodies, such as this summer’s from the MHRA.
The latest FDA 483 was in August 2018.
Comparing these observations with this year’s from Mylan certainly brings to mind a lot of thoughts about cleaning validation and contamination control.
All eight observations are repeat, some from multiple years. I find this troubling given the June 2018 Close Out letter to the 2017 Warning Letter.
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