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

Source: https://www.keypedia.com/records/483/utah-medical-products-inc/ecf52c31-9307-4120-b365-c51e5079c59e

> FDA 483 for Utah Medical Products, Inc on March 12, 2003. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Utah Medical Products, Inc
- Inspection Date: 2003-03-12
- Product Type: Devices
- Office Name: Denver District Office
- Summary: 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

## Related Officers

- [Executive Director](https://www.keypedia.com/people/karen-a-coleman/40d3d64e-ae3d-4f49-889b-1bce21e8d3ef)
- [Director, Investigations Branch](https://www.keypedia.com/people/ricki-chase-off/80271f52-d172-46ac-807d-20381cc3866a)

Company: https://www.keypedia.com/companies/utah-medical-products-inc/1143ac77-8f00-400a-ad3e-b4b829f76f0e

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face