FDA 483 - Wasatch Product Development, LLC - October 29, 2004

An FDA inspection of Wasatch Product Development, Inc. in Draper, UT, revealed 32 significant deficiencies in their drug manufacturing operations. The firm lacked numerous essential written procedures for production, process controls, equipment cleaning, employee training, and comprehensive record-keeping. These widespread issues indicate a systemic failure to adhere to current Good Manufacturing Practices, posing a high risk to the quality, identity, strength, and purity of their drug products.