FDA 483 - Wasatch Product Development, LLC - March 04, 2016

Wasatch Product Development, LLC, an OTC drug contract manufacturer in Draper, UT, was cited for significant deficiencies in its quality control unit, including inadequate annual product reviews, change control, and out-of-specification investigations. The firm also failed to follow validation protocols and maintain specific cleaning validation documentation. Additionally, the firm did not calculate actual and theoretical yields during the packaging phase of drug products, indicating a lack of adherence to good manufacturing practices.