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Protein Supplement Maker Fails FDA Audit -- Many Products Affected

calpoly

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ProteinFactory 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.

Theta Brothers Sports Nutrition, Inc. 4/2/12
 
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wow! I'm not sure that Im reading this correctly, but it sounds like pf.com is having issues meeting label claims?? I was just about to put in another big order and trying to decide between a pf.com custom mix and trutien. As I was comparing, I was wondering how pf.com can offer such superior powders at a fraction of the cost...is this how?
 
wow! I'm not sure that Im reading this correctly, but it sounds like pf.com is having issues meeting label claims?? I was just about to put in another big order and trying to decide between a pf.com custom mix and trutien. As I was comparing, I was wondering how pf.com can offer such superior powders at a fraction of the cost...is this how?
IMO proteinfactory is still pretty expensive, regardless of their sanitation issues. I use Dante's trueprotein all the way.
 
the fact that they may not be property cleaning machines between two different types of powders doesnt concern me much, but is what they say is in the bottle really in the bottle?
 
This is pulled from the FDA article:

- You failed to verify that your finished batches of dietary supplements meet product specifications for identity, purity, strength, and composition, and for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch, as required by 21 CFR 111.75(c).

And this looks like an ongoing problem(2002):

http://www.elitefitness.com/forum/b...n-factory-fails-label-claims-test-181883.html
 
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