FDA 483 - Utah Medical Products, Inc - March 12, 2003

This FDA Form 483 details observations from an inspection, indicating multiple deficiencies in the facility's quality system and manufacturing processes.

**Key Violations and Observations:**

* **Validation Deficiencies:** * Processes whose results cannot be fully verified by subsequent inspection and test were not adequately and fully validated and approved. * Software validation activities for computers or automated data processing systems used in production and the quality system were not documented. * Specific computer software was not validated for its intended use. * **Corrective and Preventive Action (CAPA) System Issues:** * Procedures for analyzing quality data to identify causes of nonconforming product or other quality problems were incomplete. * Not all necessary actions to correct and prevent recurrence of nonconforming product were identified. * CAPA actions were not verified or validated for effectiveness and to ensure no adverse effect on the finished device. * **Medical Device Reporting (MDR) Non-Compliance:** * An MDR report was not submitted within 30 days of becoming aware of information suggesting a marketed device malfunction likely to cause or contribute to death or serious injury if recurring. * **Environmental and Process Control Lapses:** * Procedures for controlling environmental conditions were not documented and followed. * Process control procedures describing necessary controls to ensure conformance to specifications were not established. * **Equipment and