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FDA Warning Letters: May 1, 2012 Update

From the U.S. Food and Drug Administration warning letters posted May 1, 2012:

Florida’s Finest Seafood Company of Lauderhill, FL warned that a February/March 2012 inspection of the company’s seafood processing facility revealed that its seafood Hazard Analysis and Critical Control Point (HACCP) plan lacked adequate controls for pathogenic bacteria growth, C. botulinum growth or toxin formation for crabmeat and smoked salmon.

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Vince & Sons Pasta Company of Bridgeview, IL warned that a February/March 2012 inspection of the company’s processing facility found that it lacked a seafood Hazard Analysis and Critical Control Point (HACCP) plan for vacuum packaged lobster to control the hazard of C. botulinum growth, and that no one in the firm had completed the required HACCP training or was HACCP qualified through job experience to qualify for compliance. 

SEI Pharmaceuticals of Miami, FL warned that a September 2011 inspection of the company’s dietary supplement manufacturing facility revealed significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, including failure to establish product specifications, determine whether those specifications were met, ensure uniformity in finished products from batch to batch or to establish written procedures for lab operations, or to adequately clean all equipment and surfaces between productions batches.

Oriental Packing Co. of Miami, FL warned that a December 2011/January 2012 inspection of the company’s spice processing facility documented serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, including using the same equipment to mix products that contained both non-allergenic and allergenic ingredients, failing to adequately clean and sanitize equipment, storing raw ingredients in bags not sealed to protect against contamination, and storing plastic package lids against a wall on the floor of the packaging area, among other things. In addition, the inspection cited labeling issues, such as naming a product “Flavor Enhancer” rather than monosodium glutamate.

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