The most recently posted food-related warning letters from the U.S. Food and Drug Administration went to a sprout operation, two seafood importers, a seafood processor and two dairy farms. Chicago’s Indoor Garden was sent a warning letter on March 25 regarding an inspection FDA conducted from May 11-14, 2015, at the company’s sprout operation at 4459 Division St. in Chicago. “During the inspection, we documented insanitary conditions and practices that render your green sprouts, wheatgrass, sunflower greens, pea shoots, and sprouted beans adulterated” under the Federal Food, Drug, and Cosmetic Act, FDA wrote. Investigators observed rodent droppings, insect-like bore holes in seed bags, and live and dead insects throughout the sprouting operation, according to the warning letter. Other problems cited were an employee “repeatedly wiping their nose with a gloved hand and then returning to packaging finished red clover sprouts without washing or changing the gloves or washing their hands.” FDA also noted that the firm soaks all seeds used to grow ready-to-eat green sprouts, wheatgrass, sunflower greens, pea shoots and beans without sanitizing chemicals or antimicrobial treatment. The letter stated this was a repeat observation documented during previous inspections in 2011 and 2012. FDA recommends treating seeds for sprouting with one or more treatments, such as 20,000 ppm calcium hypochlorite, that have been approved for reduction of pathogens in seeds or sprouts, the letter pointed out. The agency stated that condensate from the evaporator unit was observed actively dripping directly over uncovered bins of red radish sprouts in the walk-in cooler. “We recommend that you take appropriate steps to protect your food from potential contamination from building surfaces through condensation or drip from these or other surfaces,” FDA wrote. The firm submitted corrective actions to FDA on May 28, 2015, but the agency found that the problems “have not been adequately addressed.” FDA sent a warning letter to SuperValu Inc. on Sept. 20 to say that “serious violations” of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations had been noted during an inspection of its seafood processing facility in Denver, PA, performed between Aug. 10 and 19. The firm did not take corrective action to control pathogenic bacterial growth or toxin formation when its process for storing seafood products deviated at a critical control point, FDA wrote, adding that an investigator documented 21 instances of temperature abuse between June 2 and Aug. 10. “No corrective actions were documented in any of these instances,” according to the warning letter. The company’s response to this observation was deemed inadequate because FDA stated that no evidence of testing or training was provided. In a warning letter dated Sept. 15, FDA told Frontier Japan Inc. that its seafood importer establishment in New York City had serious seafood HACCP violations when it was inspected on July 14. Imported fish must be processed under conditions that are equivalent to those required of domestic processors, FDA wrote. Because this did not occur, the firm’s imported fresh fillet yellowtail fish are adulterated “in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health,” the letter stated. Arcadia Trading Inc. of Brooklyn, NY, was told in a Sept. 14 warning letter that a July 6 and 7 inspection of its seafood importing firm identified “serious violations” of the federal regulations, rendering its refrigerated, vacuum-packed, salted croaker adulterated under the law. The company’s response dated July 22 was found to be inadequate, FDA wrote, because it did not provide an adequate affirmative step to make sure that the imported product is processed in accordance with the seafood HACCP regulations. “Your product specifications should state that the dried or salted croaker fish will be fully eviscerated and processed in accordance with Good Manufacturing Practices,” the agency’s letter noted. On Aug. 22, FDA wrote to Varel Farms LLC about an investigation conducted June 23-29 at its dairy operation in Bartelso, IL. The letter stated that on or about Feb. 18, the farm sold a cow for slaughter as food. USDA analysis of tissue samples from this animal identified the presence of desfuroylceftiofur, a marker residue for ceftiofur, in the kidney tissue at a level of 21.47 parts per million, the agency pointed out. However, FDA’s tolerance level is 0.4 ppm for residues of desfuroylceftiofur in the edible tissues of a cow. The investigation also revealed that the dairy operation failed to maintain complete treatment records, according to the warning letter. A warning letter went out to Tensen Dairies LLC on June 17 to say that FDA investigators had found violations of the Federal Food, Drug, and Cosmetic Act during an investigation conducted Feb. 23 through March 2 at the dairy operation in Effingham, IL. On or about Oct. 14, 2015, Tensen Dairies sold a cow for slaughter as food, FDA wrote. Analysis of tissue samples collected from this animal identified the presence of ampicillin at .26 ppm in the kidney tissue, according to the warning letter, while FDA has established a tolerance of 0.01 ppm for residues of ampicillin in the edible tissues of cattle. The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated, the agency stated. A failure to maintain complete treatment records was also mentioned. Recipients of FDA warning letters have 15 working days from receipt to respond with details of the procedures they have taken, or will take, to correct the current violations and prevent them from recurring.
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