FDA 483 - Variamed, LLC - December 18, 2024

Variamed, LLC in Chattanooga, TN, a specification developer of Class I and Class II medical devices, received a Form FDA-483 with 12 observations. The inspection revealed a severe lack of fundamental quality system procedures, including design control, purchasing, CAPA, complaint handling, medical device reporting, and unique device identification requirements. These deficiencies indicate a comprehensive failure to establish and maintain a compliant quality system.