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

CardioFocus, Inc. in Marlborough, MA, underwent an FDA inspection from August 8-11, 2022, resulting in three observations. The inspection revealed deficiencies in complaint handling procedures, including failure to close a significant number of complaints and inadequate procedures for Accidental Radiation Occurrences. Additionally, the firm failed to perform required qualifications for manufacturing equipment used in catheter production.