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FDA Warning Letters: April 3, 2012 Update

From the U.S. Food and Drug Administration warning letters posted since our March 27, 2012 update:

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– Prospect Enterprises of Los Angeles, CA was warned that a January/February 2012 inspection of the company’s seafood processing facility, American Fish & Seafood Company in Sacramento, CA revealed violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation so that its chilled, histamine-forming fish such as tuna, chilled, vacuum packaged Hamachi and tuna, as well as refrigerated ready-to-eat products such as vacuum packaged smoked salmon and trout, and pasteurized canned crabmeat, would be considered adulterated.

The FDA said the inspection also revealed deviations from the Current Good Manufacturing Practice regulation for foods, including inadequate monitoring of cooler storage to control pathogen growth and toxin formation including Clostridium botulinum toxin.

– Plenus Group of Lowell, MA was warned that a February/March 2012 inspection of the company’s seafood processing facility revealed violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation so that its refrigerated clam chowder in reduced oxygen packaged bags would be considered adulterated.

– Meherrin Agricultural & Chemical of Severn, NC was warned that a November/December 2011 inspection of the company’s Hampton Farms Industrial peanut butter processing plant revealed violations of the Current Good Manufacturing Practice regulation for foods, such as using a band saw to cut the bottoms off customer-returned 18 oz. plastic jars of peanut butter.

The FDA said peanut butter from some of these jars was subsequently reworked into new product, at a post-kill step. The FDA letter acknowledged that on Dec. 6, 2011, the company destroyed barrels containing 10 oz. jars of peanut butter product intended for rework that were under embargo by the North Carolina Department of Agriculture and Consumer Services.

The letter also detailed measures that must be taken to exclude pests from processing areas and ensure that floors, walls and ceilings are kept clean and in good repair.

– Protica of Whitehall, PA was warned that a September/October 2011 inspection of the company’s facility revealed violations from the requirements of the Acidified Foods Current Good Manufacturing Practice regulations for its acidified protein and energy drinks, acidified protein gelatin snacks and acidified dietary supplements, including conducting multiple microbiological tests when the initial or consecutive microbiological tests failed.   

Distribucion Y Representaciones Comerciales of Santiago, Chile was warned that a November 2011 inspection of the company’s juice processing facility in Fundo El Escudo S/N, Teno, Curico, Chile revealed violations of the juice Hazard Analysis and Critical Control Point regulation, including the lack of a written hazard analysis or a written HACCP plan for the 100% shelf-stable bottled Apple Juice, Plum Juice, Quince Juice, and Grape Juice it manufactured and previously exported to the United States to control the hazards of pathogens, chemicals, heavy metals, patulin, pesticides, metal or glass.

The letter also noted deviations from the Current Good Manufacturing Practice regulation for foods, including standard procedures for monitoring the cleanliness of food contact surfaces, prevention of cross-contamination, maintenance of hand-washing facilities and other key areas of sanitation.

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