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

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),