FDA 483 - Wasatch Product Development, LLC - April 09, 2019

During an inspection, Wasatch Product Development, LLC, a dietary supplement contract manufacturer in Draper, UT, was cited for significant deficiencies in its quality control operations. The firm failed to establish and follow written procedures for quality control, including valid testing methods for raw materials and finished products. Additionally, the company lacked finished product specifications and did not create master manufacturing records for each unique batch size of dietary supplements produced.