FDA EIR - Wasatch Product Development, LLC - October 29, 2004

An FDA inspection of Wasatch Product Development (WPD), a contract manufacturer of OTC drugs and cosmetics, was conducted from October 25-29, 2004. The inspection assessed the company's compliance with regulatory standards for both product types, focusing on activities from July 2003. While the cosmetics program revealed no objectionable conditions, the drug manufacturing operations received an "Official Action Indicated" classification, signifying significant concerns.

The primary issues, detailed in an FDA-483 form issued to President Mark Ward, centered on substantial deficiencies in adherence to Current Good Manufacturing Practices (cGMPs) for drug products. Specific violations included a lack of formal written procedures, inadequate record keeping, and an absence of process and cleaning validation protocols. Furthermore, facility-related problems were identified, such as overcrowding, insufficient hand washing facilities, and poor housekeeping practices.

As a result of these findings, WPD is required to address the identified violations promptly. A sample was collected to document deviations from cGMPs. A reinspection was planned for June 2005 to verify that corrective actions have been implemented and are effective. Correspondence related to the inspection should be directed to Mr. Ward at WPD and copied to Dave Wentz of USANA Health Sciences, Inc.