# FDA 483 - Utah Medical Products, Inc. - April 15, 2002

Source: https://www.keypedia.com/records/483/utah-medical-products-inc/e2b813b1-7cbe-46b8-947e-a05c21c9c874

> FDA 483 for Utah Medical Products, Inc. on April 15, 2002. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Utah Medical Products, Inc.
- Inspection Date: 2002-04-15
- Product Type: Devices
- Office Name: Denver District Office
- Summary: This FDA Form 483 details observations from an inspection of a medical device manufacturer, focusing on the IUP line of devices.

**Key Violations and Observations:**

*   **Validation Deficiencies:**
    *   Lack of raw test data or validation protocols for X and X sterilizations of the IUP devices.
    *   No evidence to support a five-year expiration date.
    *   Inadequate testing for second X sterilization exposure, lacking physical integrity tests and statistical rationale for sample size.
    *   Unclear sterilization methods and device counts in a memo regarding X.
    *   No evidence of X sterilization validation for the IUP device in a X.
*   **Corrective/Preventive Action (CAPA) Issues:**
    *   CPAR X for cracked lumens lacked a review of preventative maintenance, mold qualification, machine parameters, and Device History Records (DHRs).
*   **Device History Record (DHR) Inaccuracies:**
    *   DHRs for Intran Plus product line did not document disposition of all devices within a lot, showing discrepancies in accepted vs. released units.
    *   DHRs inaccurately reflected in-process testing, with individuals signing off not being the actual performers, and lack of verification of inspection results.
    *   DHRs did not reflect retest/rework activities, which were allowed without Non-Conforming Materials Reports (NCMRs),

## Related Officers

- [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/f74bfb1e-47f5-45dd-94db-fb865640fa8a

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