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04-22-2012, 03:20 PM #1
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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.
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04-22-2012, 03:55 PM #2
Interesting. I use protein factory's native whey isolate. Maybe I will go back to Optimum after reading this...
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04-22-2012, 04:00 PM #3
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04-22-2012, 04:02 PM #4
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04-22-2012, 04:09 PM #5
I use Dymatize, glad to see they're not a part of this news
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04-22-2012, 04:16 PM #6
good thing i use true nutrition stuff.
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04-22-2012, 04:35 PM #7
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04-22-2012, 04:56 PM #8
Here is the actual FDA letter:
http://www.fda.gov/ICECI/Enforcement.../ucm299891.htm
Looks like it is basically all the proteinfactory.com products, since it all gets manufactured at that facility, as far as I know.
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04-22-2012, 05:13 PM #9During the inspection, you informed our investigator that you intended to correct these violations by telling your employees "not to hit the bottom of the pot with the mixer." This proposed corrective action will not sufficiently protect against contamination.
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04-24-2012, 01:38 AM #10
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04-24-2012, 01:49 AM #11
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04-24-2012, 02:51 AM #12
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trueprotein all the way
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04-24-2012, 03:02 AM #13
Certain people portray governmental agencies as wasteful spending, but this is a good example of how administrative oversight can protect the consumer. It would be great if supplement companies voluntarily submitted their products for 3rd-party purity tests, but in the absence of that, I hope the FDA continues to conduct these inspections.
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