FDA 483 - Utah Medical Products, Inc - March 03, 2004

An FDA inspection of Utah Medical Products, Inc., a medical device manufacturer located in Midvale, UT, was conducted from February 2 to March 3, 2004. The inspection revealed significant deficiencies across multiple aspects of the company's quality system, indicating a lack of adherence to medical device regulatory requirements. The main violations centered on inadequate process validation for critical manufacturing operations, including extrusion, injection molding, material drying, and annealing processes, where control limits and equipment installations were not properly supported or challenged. In-process product acceptance procedures were found to be insufficient, with manufacturing processes exceeding established control limits and discrepancies in equipment setup parameters. The company also failed to validate key computer software systems used for complaint handling and tracking quality system data like Corrective and Preventive Actions (CAPA) and nonconforming materials. Furthermore, procedures for corrective and preventive actions were deficient, lacking clear guidance on data analysis and leading to inconsistent complaint coding and incomplete tracking of product lot numbers associated with defects. Complaint handling procedures were also inadequate, failing to define or document the evaluation of complaint history. Lastly, device history records contained errors, such as obsolete sampling methods and missing critical process data, that were not detected during review. To address these observations, Utah Medical Products, Inc. is required to implement comprehensive corrective actions to validate manufacturing processes, enhance in-process controls, validate all relevant software, improve CAPA and complaint handling procedures, and ensure complete and accurate device history records.