FDA 483 - Medical Informatics Corp. - August 02, 2019

Medical Informatics Corp. in Houston, TX, a medical device manufacturer, received a Form FDA 483 with seven observations following an inspection. The observations highlight significant deficiencies in the firm's quality system, including inadequate procedures for complaint handling, MDR reporting, employee training, and labeling control. Additionally, issues were noted with device software validation documentation and the completeness of risk analysis, indicating a need for comprehensive improvements in their quality management system.