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Posted April 16, 2012

Protein Supplement Maker Fails FDA Audit -- Many Products Affected

The FDA sent a Warning Letter (dated April 2, 2012) to Theta Brothers Sports Nutrition, Inc. regarding numerous violations of good manufacturing practices at its Lakewood, New Jersey facility. Among the violations cited were failure to adequately clean equipment to ensure that ensure that preceding products do not contaminate subsequent products. For example, an FDA investigator found that the company manufactured its Egg White Protein product followed by non-egg containing products (WPC/Dextrose Vanilla).

The company also failed to test that dietary supplements products, such as Rifle Protein Vanilla, PeptoPro Lemon Lime, WPC/Dextrose Vanilla, CFM Whey Isolate, Goat Whey Protein Concentrate, and Custom Protein Factory Mix, met specifications for identity, purity , strength, and composition. Products affected by the violations include the following: Rifle Protein Vanilla, PeptoPro Lemon Lime, WPC/Dextrose Vanilla, CFM Whey Isolate, Goat Whey Protein Concentrate, and Custom Protein Factory Mix, Pure Vanilla 2 lb., Pure Chocolate, Rifle Protein Vanilla, Whey Light Chocolate, Egg White Protein Natural Vanilla, WPC/Dextrose Vanilla, Creapure Creatine Monohydrate, Glutamine Peptides, WPC Vanilla, WPC Chocolate, 100% Oat Muscle, Big Blast Chocolate, Weight Loss MRP, Omega Muscle, Post Workout Chocolate, Carb Energy, Native Whey, Membrane Micellar Casein PO, Penta Protein, Big Blast Chocolate Peanut Butter, Anabolic Cream, Cinnnabun, Super Plasma, Complete Protein Powder, Protein Factory Anabolic Cream Chocolate Milk, Pure Egg White Protein, Grape, Fruit Punch and Hydrolyzed Whey Protein Vanilla, High Protein Whey Botanical Blend Wild Vanilla and Mocha, and Protein Factory Zip.

For more information about the Warning Letter, use the link in red below.

For ConsumerLab.com's tests of related products, see the Review of Protein Powders, Drinks and Shakes.