Medtech Insight is part 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

UsernamePublicRestriction
UsernamePublicRestriction

FDA Stats On 483 Observations Show Firms Grappling With Complaint Handling

This article was originally published in The Silver Sheet

Executive Summary

FDA STATISTICS SHOW THAT COMPLAINT HANDLING continues to confound some medical device manufacturers, with 11% of FDA-483 observations in 2005 noting violations of that Quality System Regulation requirement. The agency says firms need to make sure they’re performing adequate complaint investigations to discover the root causes of nonconforming devices, as well as strengthen their complaint handling procedures. "We see a lot of firms having the least effective corrective and preventive action possible" because they perform the quickest and easiest fix for a problem, FDA Quality Systems Expert Kim Trautman says. Three companies describe their approaches to complaint handling, including Gambro Renal Products, which is instituting changes to help lift two recent FDA warning letters that cited complaint handling deficiencies...
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT036115

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

Cancel