Just released from FDAnews — Investigations Operations Manual 2014 — the FDA’s own internal guidance on how to inspect a drug or device company. Know what the investigators look for — before they even get there.
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