483
Hospira, Inc., A Pfizer CompanyHospira, Inc., A Pfizer Company – FDA 483, Jun 30, 2023
Record Details
An FDA inspection of Hospira Inc., A Pfizer Company in Mcpherson, KS, identified a significant issue related to the prevention of microbiological contamination in sterile drug products. The inspection observed apparent leaks in the (b) (4) system on two separate occasions, indicating a failure to establish and follow appropriate written procedures. These findings suggest potential risks to the sterility of drug products manufactured at the facility.
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ID · b5f34599-a21b-4d1e-a587-4d0b84148ab9
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