FDA WarningA cattle producer, a juice producer and a bottled water producer were sent warning letters in the U.S. Food and Drug Administration’s latest batch posted last week. Byron Kramer Inc.‘s cow/calf operation in Holyoke, CO, sold a steer for slaughter as food, which lab tests found had florfenicol at 6.52 parts per million (ppm) in its livxer tissue, florfenicol at 2.07 ppm in the muscle tissue, and sulfamethazine at 10.12 ppm in the liver tissue, FDA stated in its Sept. 28 warning letter. The agency has established tolerances of 3.7 ppm for residues of florfenicol in liver tissue of cattle and 0.3 ppm in muscle tissue of cattle. The established tolerance for sulfamethazine residues in uncooked edible tissues of cattle is 0.1 ppm. The presence of these drugs in edible tissues from this animal in these amounts causes the food to be adulterated, FDA stated. FDA’s Oct. 7 letter to Pat’s Exotic Beverages in Bronx, NY, referred to “serious violations” of the juice Hazard Analysis and Critical Control Point (HACCP) regulation. Some of the agency’s warnings were about failure to produce validations studies to show that pasteurization processes adequately reduce microorganisms, failure to list allergens as a food safety hazard in the carrot-beet juice HACCP plan, and inadequate monitoring procedure(s) or frequencies that couldn’t ensure compliance with the identified critical limits. Certain of the company’s products were also considered misbranded for various reasons, including a lack of percentages of juice, certain nutrition information, and a declaration of chemical preservatives in the labeling. Paks Clothiers Inc., of El Monte, CA, doing business as Aqua Pure Drinking Water, was cited Sept. 30 for violations which render the bottled water products processed at the facility adulterated, FDA stated. The company did not take enough samples of each type of bottled water produced or quantify any coliforms present and did not document tests of cleaning and sanitizing solutions to assure adequate performance, the warning letter stated. All bacteriological swabs and/or rinse counts from multiuse containers must be free of coliform organisms in order to meet the requirements, but according to tests, one of the company’s five-gallon container yielded coliforms, FDA stated. The agency also considers the 5-gallon Aqua Pure Drinking Water product misbranded because the label fails to state “from a community water system,” or “from a municipal source”, as appropriate, on the principal display panel or panels and fails to bear a label containing the place of business of the manufacturer, packer, or distributor, FDA added. Each company was given 15 days to respond to the concerns raised by FDA in the warning letters. (To sign up for a free subscription to Food Safety News, click here.)