FDA 483 - Klyo Medical Systems, Inc. - July 18, 2019

Klyn, Medical Systems, Inc. in Doral, FL, a medical device manufacturer, was cited for two observations during an FDA inspection. The firm failed to maintain adequate written Medical Device Reporting (MDR) procedures to ensure all reportable events are submitted to the FDA. Additionally, their quality audit procedures were not adequately established, specifically regarding the scope of internal audits to cover all applicable areas and demonstrate compliance with 21 CFR Part 820.