FDAnews Device Daily Bulletin

CAPA Violations Top Recent GMP Warning Letters for Devices

April 2, 2009
Devicemakers preparing for an FDA inspection should pay attention to their corrective and preventive action (CAPA) procedures, according to an analysis of recent FDA warning letters. The review of 10 recent warning letters sent to devicemakers shows CAPA problems were cited 18 times. Since many inspectors audit both device and drug companies, they tend to place more emphasis on CAPA or production and process controls as auditors are more comfortable reviewing them for both types of inspections, Kim Trautman, CDRH’s good manufacturing practice (GMP) expert, said.
Devices & Diagnostics Letter