FDA 483 - Universal Synergetics Inc. - September 13, 2016

An FDA inspection of Universal Synergistics Inc. Dba T.H.E.M. in Marlton, NJ, revealed a significant quality control issue. The firm failed to ensure that its finished dietary supplement products met established specifications for identity, purity, strength, and composition. This was due to a lack of finished product testing by the firm's QA Department and no record of such testing by their customers prior to product release.