Utah Medical Products Did Not Deviate From Good Manufacturing Practices

SALT LAKE CITY - A federal judge ruled on Oct. 21 that validation of drug companies' 'good manufacturing practices' is not limited to standards found in two documents the Food and Drug Administration has relied on in enforcement actions. USA v. Utah Medical Products Inc., et al. No. 2:04-cv-733 (D. Utah).

The FDA claimed that Utah Medical Products Inc. violated the federal Food Drug and Cosmetic Act because the methods, facilities and controls the company used for manufacturing, packing and storing its medical devices deviated from the 'good' manufacturing practices found in The Quality System Compendium (Association for the Advancement …