FDA 483 - Geneva Mfg. LLC - November 15, 2023

An FDA inspection of Geneva Mfg, LLC in Las Vegas, NV, a dietary supplement contract manufacturer, revealed significant deficiencies in quality control and manufacturing practices. The firm failed to establish adequate specifications for component identity, purity, strength, and composition, as well as for finished dietary supplements. Additionally, issues were noted with contamination limits, the release of untested raw materials, and the proper documentation and quarantine of non-conforming batches.