FDA Flags Up Repeat Issues At Pfizer's McPherson Plant in Kansas
Problems persist at Pfizer’s US manufacturing facility in McPherson, Kansas, after an FDA audit led the agency to issue a ‘Form 483’ report with eight observations, seven of which were repeated from inspections dating back to as far as 2012.
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Industry groups suggest that the drug shortage crisis needs to be addressed by changing the economic model for reimbursement, while US FDA can help by making it easier for manufacturers to use “standby” facilities as needed to bridge supply gaps and by providing generic drug manufacturers with more notice on when applications will be approved.
Pfizer’s long-standing sterile injectable supply and manufacturing issues pummelled respective sales in the US in 2018. But the US-based multinational is eyeing a string of oncology biosimilar launches in 2019, which could see biosimilar sales tick past US$1 billion.