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Home » Biopsy Sciences Gets 483 for Lax CAPA, Supplier Quality Qualms
Biopsy Sciences Gets 483 for Lax CAPA, Supplier Quality Qualms
March 5, 2012
Corrective and preventive action (CAPA) procedures at Biopsy Sciences’ Clearwater, Fla., facility do not ensure analysis of all quality data sources to identify “recurring” quality problems with its HydroMARK breast biopsy site marker and other devices, an FDA Form 483 states.