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FDA Warning Letters: April 10, 2012 Update

From the U.S. Food and Drug Administration warning letters posted since our April 3, 2012 update:

Lucky Taco, Inc. of Hustisford, WI was warned by the FDA that a December 2011 inspection of the company’s facility revealed significant violations, including that its Java Mint flavored Lucky Cruncher Cookie contained a coffee liquer flavor with color additives not declared on the label and that its Lucky Taco Mexican Fortune Cookie containued milk, an allergen not declared on the label. The FDA also challenged the company’s “low calorie” claims for some of its products.

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Health One Pharmaceuticals, Inc. of El Monte, CA was warned by the FDA that a September/October inspection of the company’s dietary supplement manufacturing facility revealed serious violations of FDA’s Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, including failure to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient

Fells Point Wholesale Meats, Inc. of Baltimore, MD was warned by the FDA that a December 2011 inspection of the company’s pet food manufacturing and seafood warehouse facility revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, including failure to have HACCP plans for seafood products such as pasteurized swimming crabmeat, vacuum-packed smoked salmon and pickled herring, to control the food safety hazards of pathogen growth and toxin formation from time/temperature abuse. The warning letter also cited some sanitation issues.

 

 

 

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