RAPS

Make CAPA ‘cool’: FDA gives thumbs-up to framework that retools CAPA process for device makers

A new framework that rethinks the corrective and preventive action (CAPA) process by using a risk-based approach has been given the thumbs-up by the US Food and Drug Administration (FDA), with one ...
PharmTech

Responding to FDA CAPA Requests

When FDA oversight detects violations of current good manufacturing practices (CGMPs) at a drug manufacturing facility, the owner is expected to respond with a corrective and preventive actions (CAPA) ...
RAPS

FDA warns five device makers for Quality System, CAPA issues

The US Food and Drug Administration (FDA) has warned five medtech companies for failing to meet current good manufacturing practices (CGMP) requirements under the Quality System (QS) regulations. The ...
MD&M East

Best Practices: Managing a CAPA System

Establishing a corrective and preventive action (CAPA) system is a quality system regulation (QSR) requirement for medical device firms marketing products in the United States. Although FDA has always ...