FDA 483 - Wasatch Product Development, LLC - March 11, 2011

Wasatch Product Development, LLC, an OTC drug manufacturer in Draper, UT, was cited for numerous significant deficiencies during an FDA inspection. The firm lacked fundamental written procedures for production and process controls, failed to validate manufacturing processes and equipment, and did not adequately investigate out-of-specification results. These issues indicate a severe lack of control over critical aspects of drug manufacturing, potentially impacting product identity, strength, quality, and purity.