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Home » FDA Slaps Samsung Biologics With Form 483 Over Data Integrity Issues, Quality Lapses
FDA Slaps Samsung Biologics With Form 483 Over Data Integrity Issues, Quality Lapses
The FDA smacked Samsung Biologics for using technology to support application submission testing that had inadequate data integrity controls, among other lapses, following an inspection of its Incheon, South Korea, facility conducted in August and September.