FDA 483 - Maxkron Machine, LLC - May 13, 2022

During an inspection conducted from May 11-13, 2022, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Maxkron Machine, LLC, a medical device manufacturer located in Valencia, CA. The inspection identified a significant observation concerning the company's quality system practices. The primary issue noted was the absence of documented process validation activities and their results for the CNC machines utilized in contract manufacturing Class II medical devices. Specifically, while the equipment was installed and validated, the required Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities, along with their resulting set parameters, were not properly documented or recorded. This indicates a gap in adhering to essential quality system requirements designed to ensure consistent manufacturing processes and product quality for medical devices. Maxkron Machine, LLC is responsible for promptly addressing this observation by implementing corrective actions to ensure all process validation activities and their outcomes are thoroughly documented and maintained in compliance with medical device regulations. The firm acknowledged the observation and reportedly committed to correcting the deficiency.