The FDA issued a warning letter to US Vascular for failing to correct deficiencies in its complaint reviews and to fix problems with medical device reporting, among other violations.
The agency issued the warning letter following the company’s response to a Form 483 issued after a March 2018 inspection of Vascular’s Beaverton, Oregon facility.
In its response, the devicemaker promised to review design procedures, lack of procedures governing complaint handling, CAPA procedures, lack of procedures to ensure that all receiveds product and services conformed to specified requirements, failure to maintain device master records, and failure to document quality audit procedures. The company failed to provide objective evidence of its corrections or timeframes in its response.
The FDA also found that the devicemaker’s response to findings that it failed to review complaints for medical device reporting to beinadeqaute. The company promised to correct the problem but the agency has not yet received adequate corrections, according to the warning letter.
Read the warning letter here: www.fdanews.com/11-15-18-USVascularWL.pdf. — Zack Budryk