The latest posted warning letters sent out by the U.S. Food and Drug Administration (FDA) went to manufacturers and/or processors of sprouts, tofu, juice and seafood, and also to a veterinarian, a dairy farm and two cattle operations. Good Seed Inc. of Springfield, VA, was informed in a Dec. 2, 2015, letter from FDA that a June 1-3, 2015, inspection of the company’s soybean and mung bean sprout growing and packaging operation revealed Listeria monocytogenes from “multiple swabs” taken within the facility. FDA WarningFurther, FDA noted that “documented conditions and practices” in the operation were “reasonably likely to have resulted in the contamination of your product with L. monocytogenes.” The agency found that “food particles were observed on the hopper section and conveyor belt of your one (1) pound bagging machine that had been cleaned and sanitized the day prior. A swab taken from this location yielded L. monocytogenes.” FDA also noted that finished product samples collected by the Virginia Department of Agriculture and Consumer Services had yielded the same strain as that from the environmental samples. A response from the company was found to be inadequate because FDA said there were insufficient details provided in order to evaluate the corrective actions. FDA previously sent a warning letter to Good Seed dated Aug. 17, 2015, noting similar problems at the company’s VA facility. Nam & Nam Inc. (trading as Sam Sung Tofu) of Washington, D.C., was told in a Dec. 3, 2015, warning letter that a June 18-23, 2015, inspection of its tofu manufacturing facility revealed “significant violations” of the federal Current Good Manufacturing Practices and Food Labeling regulations, thereby rendering the company’s product adulterated. Specifically, FDA stated that the company failed to clean and sanitize utensils and equipment “in a manner that protects against contamination of food-contact surfaces.” Also, the agency noted, employees were not provided with adequate toilet facilities and were observed leaving and then returning to their workstations to process tofu without washing their hands. Water leaks from the ceiling onto the floor of the manufacturing area were observed within about three feet from uncovered tofu, FDA stated, and toxic cleaning compounds were not stored in such a way that would protect against contamination of food and food-packaging materials. Finally, a major food allergen (soy) was not listed on the company’s finished product labels, each ingredient was not declared on the label as required by law, the place of business was not listed on the label, and the net quantity of contents was not declared on the principal display panel, FDA stated. FDA wrote to Lehman Family Farms (doing business as Home Grown Cellars) of Madera, CA, on Dec. 2, 2015, to state that an Aug. 21-Sept. 21, 2015, inspection revealed “serious violations” of the juice HACCP regulation. The agency stated that the company is not exempt from these regulations because it sells or distributes juice products to both wholesale accounts and directly to retail customers. However, retail establishments that make and sell juice directly to consumers and do not sell or distribute to other businesses are exempt, the letter noted. FDA told the company that two critical control points for its Pomegranate Juice/Ice Wink Juice Bars product had not been validated to achieve a 5-log reduction of pertinent microorganisms, which is necessary to comply with federal regulations. Also, the company’s revised HACCP plan for the product “does not list the microbiological food safety hazards of vegetative bacterial pathogens,” FDA’s letter stated. Finally, the agency stated that the firm did not maintain sanitary monitoring records for cleanliness procedures or for prevention of cross-contamination, maintenance of hand-washing facilities, protection of food, food packaging material and food contact surfaces from adulteration with chemical, physical and biological contaminants, and exclusion of pests from the food plant. H & H Seafood of Houston, TX, was sent a warning letter on Nov. 20, 2015, noting that inspectors visiting the facility between June 3-July 7, 2015, had found “serious violations” of the seafood HACCP regulation. Therefore, the agency noted, “your pasteurized canned crabmeat, ready-to-eat crabmeat, and tuna are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.” These violations included not having HACCP plans listing a critical limit at the storage critical control points to control pathogenic bacteria growth and toxin formation, Clostridium botulinum toxin formation, and scombrotoxin formation. FDA added that the company’s corrective action plans were not appropriate. The agency noted a “significant history of violations at this facility,” including advisory letters and a regulatory meeting held in April 2014. “We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm,” the letter stated. FDA wrote to Atlanta-based Halperns’ Steak and Seafood Company LLC on Nov. 17, 2015, to inform the company of “serious violations” of the seafood HACCP regulation identified during a Sept. 22-Oct. 2, 2015, inspection of its Dallas seafood processing facility. This means the company’s canned pasteurized crabmeat, histamine forming fish, and caviar are adulterated, FDA stated. Specifically, the HACCP plan for caviar lists critical limits at the receiving critical control point that are not adequate to control pathogen growth and toxin formation, including Clostridium botulinum, the agency noted. FDA found the company’s response that caviar is not a fishery product to be inadequate, and the agency noted additional problems relating to transportation and storage temperature monitoring, as well as monitoring for the adequacy of ice. The company also did not take corrective actions for critical limit deviations involving a shipment of “Pasteurized blue crabmeat,” and the product was subsequently distributed, FDA’s letter stated. “The Food and Drug Administration has a significant history of violations associated with the most responsible personnel at this facility, including prior issued advisory letters and a regulatory meeting with the Dallas District Office. Based on our history with this facility, the findings of the current inspection, and your firm’s inadequate response; we believe a meeting with your firm’s current management is necessary,” the letter noted. In a letter FDA sent July 1, 2015, to Kalloni S.A. in Xanthi, Greece, the agency stated that the company’s seafood processing facility in Kimmeria was inspected on Jan. 26-27, 2015, and that inspectors had noted seafood HACCP violations involving processing of salted mackerel, anchovies and sardines. The company’s HACCP plan does not list critical control points to control the food safety hazards of scombrotoxin (histamine) formation and pathogen growth and toxin formation, the letter stated. “Your fish products are scombroid species and are ready to eat, consequently they pose risks for scombrotoxin (histamine) formation and pathogen growth as a result of time and temperature abuse,” FDA stated. Additional problems were noted with icing and cooling procedures, salting, and temperature monitoring during storage and transit. Van Kooten Dairy in Comanche, TX, was told in an Oct. 8, 2015, warning letter from FDA that inspectors had found violations of the Federal Food, Drug, and Cosmetic Act during an investigation of the dairy operation on July 28-29, 2015. Specifically, the dairy offered for sale on or about March 20, 2015, an animal for slaughter as food that was adulterated. Lab analysis of tissue samples from this animal identified the presence of 34.7 parts per million (ppm) of oxytetracycline in the kidney tissue and the presence of 5.48 ppm of flunixin residue in the liver tissue, the letter stated. However, FDA has established a tolerance of 12.0 ppm for residues of oxytetracycline in the kidney tissue of cattle and a tolerance of 0.125 ppm for residues of flunixin in the liver (target tissue) of cattle, according to the letter. In addition, the dairy failed to maintain complete treatment records, did not use drugs as directed by their approved labeling and/or by a licensed veterinarian’s prescription, and signed a certification stating that livestock being sold did not have illegal levels of drug residues, which FDA stated would constitute a “false guaranty” prohibited under federal law. FDA sent a letter on Nov. 24, 2015, to Rocky Mountain Veterinary Services Inc. of Shelley, ID, informing company president Kevin D. Crandall that an investigation had been done into the prescribing of drugs at his veterinary practice. According to the agency’s letter, the new animal drug PenOne Pro Penicillin G Procaine, NADA 065-010, had been used in such a way that three animals were offered for sale for slaughter as food that were adulterated under federal law. Specifically, FDA stated, doses of this drug were prescribed based on inappropriate weight and withdrawal times and failure to check whether the specific penicillin brand was an extended release formula, which can affect withhold times. As a result, animals were offered for slaughter as food that “were subsequently found to contain illegal residues in the edible tissue,” FDA stated. On Dec. 1, 2015, FDA sent a warning letter to Baroun Farms of Whitelaw, WI, stating that an investigation of the replacement heifer operation there had been done on Sept. 18 and Oct. 9, 2015. On or about June 29, 2015, the company sold a heifer for slaughter as food whose kidney tissues were found to contain desfuroylceftiofur at 1.85 parts per million (ppm), FDA stated. However, the agency’s tolerance level is 0.4 ppm residues of desfuroylceftiofur in the uncooked edible kidney tissue of cattle. Also, FDA told the farm operation that treatment records for medicated animals and a drug inventory of drugs used to medicate livestock were not being maintained. Gregory S. Stone of Austinville, VA, was sent a warning letter from FDA on Dec. 2, 2015, stating that an investigation of the cattle farm on Sept. 16 and 23, 2015, revealed violations of the Federal Food, Drug, and Cosmetic Act. Specifically, the agency stated that the farm offered for sale an animal for slaughter as food on or about Jan. 29, 2015, which was later found to have sulfamethazine at 38.14 parts per million (ppm) in its liver tissues. FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the uncooked edible tissue of cattle, the letter noted. In addition, FDA stated that records were not maintained on the treatment or identity of animals transported and delivered for sale, there was no adequate inventory system for determining the quantities of drugs used to medicate cows, and expired drugs were held in inventory. Also, the new animal drug Sustain III (sulfamethazine antibacterial, NADA #120-615) was not used as directed by its approved labeling, according to the letter. Recipients of these warning letters have 15 working days from receipt to outline specific steps they have taken to come into compliance with the law. 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