FDA 483 - Korvis, LLC - September 13, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 997e0849-ab44-4007-8f91-2e8a159416dd