FDAnews has teamed Chris Sloan, Quintiles Consulting, and Michael Morton, Medtronic, in a 90-minute presentation on the FDA advisory panel process. You’ll discover tips and guidance that are the fruit of a combined five decades of device regulatory experience.
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. FDA investigators also note in the Sept. 15, 2011, form that when Biopsy Sciences receives a complaint, CAPAs are not always taken to conduct a full investigation to determine root cause. The GMP Letter