FDA 483 - Konan Medical Inc. - November 30, 2023

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from November 27-30, 2023, Konan Medical Inc., a manufacturer based in Nishinomiya, Hyogo, Japan, was issued a Form FDA 483. The central observation noted during the inspection was the company's inadequate documentation of its corrective and preventive action (CAPA) activities. Specifically, Konan Medical Inc. failed to establish and document an effectiveness and verification plan to ensure that proposed corrective actions successfully resolved identified issues. An illustrative example involved Problem Sheet #023-0300, which concerned issues with supplied camera synchronization cable winding. For this specific problem, the firm did not document how the effectiveness of its proposed corrective actions would be confirmed and sustained. This deficiency highlights a gap in the company's quality system, which is critical for maintaining product quality and safety under the regulatory framework of the Federal Food, Drug, and Cosmetic Act. The FDA 483 communicates these inspectional observations, requiring Konan Medical Inc. to address the identified concerns by discussing objections or submitting a robust plan for corrective actions to ensure proper CAPA documentation and compliance.