FDA 483 - Celex Laboratories Inc. - February 25, 2022

Celex Laboratories Inc. in Richmond, a dietary supplements manufacturer, received a Form 483 with six observations related to significant deficiencies in their quality control and manufacturing processes. The observations highlight failures in establishing and adhering to component and finished product specifications, ensuring valid test methods, implementing proper laboratory controls, managing out-of-specification results, and maintaining consistent labeling with master manufacturing records. These issues indicate a lack of robust quality assurance for their dietary supplement products, including Vorst® Advanced Joint Formula and Vorst® Alpha Lipoic Acid.