Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Conduct CAPA Activities Appropriately, FDA Warns Manufacturers

This article was originally published in The Silver Sheet

Executive Summary

CORRECTIONS, CORRECTIVE ACTIONS AND PREVENTIVE ACTIONS are not being applied correctly by manufacturers, FDA says. "Corrections are spot fixes for a particular product or issue [and] are followed by corrective actions, which are more systemic," says FDA/GMP expert Kim Trautman. Further, she often sees "so many things called 'preventive actions' that aren't preventive actions." A Global Harmonization Task Force draft guidance on the topic may clear up industry confusion. It details a four-part approach that companies can use when launching a CAPA system, including identifying quality data sources, analyzing data, conducting investigations and keeping top management informed. Device firms Becton Dickinson (BD) and AGA Medical also explain how they apply risk management principles to determine whether product problems should be elevated to their CAPA systems

Related Content

Manufacturers Falling Down On Quality Data Collection And Analysis, FDA Warns
How Guidant's Poor CAPA System Played A Role In Device Troubles





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts