FDA 483 - CardioFocus, Inc. - August 11, 2022

An FDA inspection of CardioFocus, Inc., a medical device manufacturer in Marlborough, MA, was conducted from August 8-11, 2022. The inspection resulted in a Form FDA 483, outlining three significant observations related to the company's adherence to quality system requirements under the Federal Food, Drug, and Cosmetic Act. The primary issues included inadequate maintenance of complaint files, with 353 out of 1130 complaints not closed within the firm's established timeframes. Additionally, the complaint handling procedures were found insufficient for a laser manufacturer, specifically lacking guidance and reporting criteria for Accidental Radiation Occurrences. Lastly, the company failed to perform necessary operational and performance qualifications for critical manufacturing equipment, such as the (b)(4) Fixture used in the production of the HeartLight X3 Catheter. CardioFocus, Inc. is now required to address these findings, conduct internal audits, and implement corrective actions to ensure full compliance with regulatory standards.