FDA 483 - Cardiomedix Incorporated - July 16, 2021

Cardiomedix Incorporated, an Own Label Distributor / Initial Importer in Des Plaines, IL, was cited with six observations during an FDA inspection from July 13-16, 2021. The observations primarily concern fundamental deficiencies in the firm's quality system, including a lack of established procedures for complaint handling, supplier control, quality planning, quality policy, management representation, and management review. These issues indicate a significant absence of foundational quality system elements.