FDA 483 - Premium Production LLC - April 02, 2021

Premium Production LLC, a dietary supplement manufacturer in Saint George, UT, was inspected by the FDA from March 29 to April 2, 2021. The inspection revealed nine significant violations, many of which were repeat observations from a previous 2019 inspection, primarily concerning the lack of established and followed written procedures for various quality control, manufacturing, and record-keeping operations. The firm failed to ensure product quality, proper documentation, and supplier qualification, indicating systemic issues in their quality management system.