Posted April 7, 2011

FDA Warns Manufacturer of Soy Products of Violations

The U.S. FDA published a Warning Letter on dated March 25, 2011 to Soluble Products Co., LP, regarding serious violations of Current Good Manufacturing Practices (cGMPs) in its production of Revival brand products.

Among the violations cited by the FDA was the failure to establish specifications for the identities of components in Revival Soy Pro Water Mix of various flavors; failure to verify that finished batches of Revival Brand Unsweetened Chocolate met product specifications for identity, purity, strength, and composition; and failure to establish specifications to provide sufficient assurance that products the firm receives from a supplier for packaging or labeling and distribution as dietary supplements (such as an 8-count multivitamin blister pack) are adequately identified and are consistent with its purchase orders.

Moreover, the FDA noted that the firm does not do its own testing or examination of components that are not dietary ingredients and relies on a certificate of analysis for such components. In addition, it does not qualify any of the suppliers of such components used in its products by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of their tests or examinations and maintain documentation of how it qualified the supplier.

To view the Warning Letter use the link below.