FDA 483 - Korvis, LLC - September 13, 2019

An FDA inspection of Kovois, LLC, a medical device manufacturer in Corvallis, OR, revealed two significant observations. The firm failed to adequately establish procedures for corrective and preventive actions, with specific issues noted in CAPA record completion and documentation. Additionally, the inspection found that procedures for ensuring routine equipment calibration were not adequately established, lacking proper documentation for log reviews and calibration records.