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...