FDA 483 - Utah Medical Products, Inc. - June 09, 2001

An FDA inspection of Utah Medical Products, Inc., a medical device manufacturer, was conducted from June 4-8, 2001. The inspection identified significant deficiencies in the company's quality management system, as documented in a Form FDA 483. Key observations included an inadequate Corrective and Preventive Action (CAPA) system, which failed to analyze all quality data sources, such as in-process rejects and Medical Device Reports, to identify potential problems. Furthermore, no corrective actions were documented for issues identified in trend reports. Deficiencies were also noted in Device History Records (DHRs) for Intran Plus Catheters, where manufacturing procedures did not consistently assure conformity to design specifications, and essential tests were not always documented. The disposition of rejected devices during final testing was also found to be lacking. The firm had not performed validation studies for the Intran Plus manufacturing process. The non-conforming material system was cited for 'Use As Is' dispositions that lacked proper assessment of potential adverse effects on final product quality or sufficient justification. Additionally, the company had not certified its electronic signatures to the FDA as legally binding, and lacked procedures addressing the validation, accuracy, protection, access control, and audit trail generation for electronic records and signatures. Finally, sampling plans were not consistently based on valid statistical rationales. These observations underscore the firm's non-compliance with the FDA's Quality System Regulation for medical devices. Utah Medical Products, Inc. is required to thoroughly address these findings by developing and implementing robust corrective and preventive actions to ensure the quality, safety, and effectiveness of its products.