483
PETNET Solutions IncFDA 483 - PETNET Solutions Inc - April 18, 2025
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An FDA inspection of PETNET Solutions Inc in Kent, WA, revealed a failure to implement adequate equipment cleaning procedures. Inspectors observed visible residue and corrosion on a light panel and a biohazard waste receptacle within the ISO 5 primary engineering control area and hot cell during Fluorodeoxyglucose (FDG) production. These conditions raise concerns about potential adverse effects on PET drug quality and purity.
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ID · f1536658-0855-43ce-b7a2-659ef6039354