Scrip 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


Manufacturers Falling Down On Quality Data Collection And Analysis, FDA Warns

This article was originally published in The Silver Sheet

Executive Summary

Capturing and analyzing product quality data appears to be a hiccup for many firms, but the problem can be addressed through the use of proper tools and effective monitoring of quality data sources, FDA officials explain. When quality data is added to a manufacturer’s CAPA system and properly analyzed, device problems may be discovered more quickly. Further, firms that inadequately define data sources in their procedures and mishandle information coming out of those sources will attract the notice of FDA investigators. “I would urge you to sit down with the investigator and show them your quality data elements and where the data is coming from, as well as how that information is analyzed,” said Phil Pontikos, FDA’s national expert on medical devices. “If you share those processes upfront, I think it will help expedite the inspection.”


Related Content

FDA Investigators Talk Quality Issues And Inspectional ‘Games’ Manufacturers Play
Conduct CAPA Activities Appropriately, FDA Warns Manufacturers





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