FDA WarningThe latest batch of Food and Drug Administration (FDA) warning letters made public deal with illegal drug residues in calf tissues, misbranded teas and Brazilian Corn Tamales, seafood HACCP problems, and issues with acidified food regulations. The Rupert Veterinary Clinic in Rupert, VT, was warned about extralabel use of the animal drug sulfadimethoxine. The clinic prescribed it to treat calves for pneumonia, one of which was subsequently found to have illegal residues in edible tissue. Maxwell Farms in Cambridge, NY, was cited for selling a bob veal calf for slaughter for food that was found to have desfuroylceftiofur (marker residue for ceftiofur) at 2.4 parts per million (ppm) in its kidney tissue. Woody Hill Farms in Salem, NY, was cited for selling a bob veal calf that was found to have sulfadimethoxine in its kidney tissue. There is no acceptable level of residue from the drug in calves to be processed for veal. After reviewing the labels of the Ten Ren Tea Company of San Francisco’s Ten Ren Chamomile Tea, Relaxing Tea, Chrysanthemum Tea, and Hibiscus Spice Tea, FDA said the product labeling violated the Federal Food, Drug and Cosmetic Act. All four teas were considered misbranded because their labels include some information in a foreign language, but it was not translated into English as well. In addition, the Chrysanthemum Tea and Hibiscus Spice Tea included the ingredient “Stevia leaf, tea bag cut,” which the agency does not consider generally recognized as safe (GRAS) for use in conventional foods. The Brazilian Corn Tamales produced by Pamonharia do Aguinaldo in Patos de Minas, Brazil, and shipped to the U.S. were considered misbranded because their product labels failed to declare a major food allergen (milk), the nutrition information was not in an appropriate format, and some of the ingredients listed don’t include a list of sub-ingredients, FDA stated. The P&S Ravioli Company in Philadelphia faced “serious violations” of the seafood Hazard Analysis and Critical Control Points (HACCP). The HACCP plan for its Lobster Ravioli product did not list the food safety hazards of Clostridium botulinum growth and toxin formation at the “Defrosting of Lobster Meat” critical control point during the storage of unopened vacuum packaged cooked seafood in the walk-in refrigerator prior to manufacturing. The lobster ravioli’s corrective action plan also had some problems, according to FDA. In addition, the company did not maintain sanitation monitoring records, failed to conduct proper cleaning and sanitizing operations for utensils and equipment, failed to have employees remove unsecured jewelry or other objects which might fall into food, and failed to have an employee wear a beard cover. P&S Ravioli’s Cheese Tortellini, Linguine, Alfredo sauce, and Jumbo Lobster Ravioli products were also considered misbranded for numerous reasons. An inspection of Michael Zakany’s food processing facility in Zanesville, OH, revealed “serious violations” of the Acidified Food regulations and the current Good Manufacturing Practice (cGMP) regulations for food. The company failed to process acidified foods in conformity with at least the scheduled processes, failed to test and examine containers often enough to ensure that containers suitably protect the food from leakage and contamination, failed to maintain records identifying initial distribution of finished product, failed to prepare and maintain current procedures for recalling products, and failed to maintain records of the examination of raw materials, packaging materials, and supplier’s guarantees or certificates to verify compliance with FDA regulations and guidelines. Furthermore, employees did not wash and sanitize hands thoroughly in an adequate hand-washing facility, and the FDA inspection uncovered a lack of precautions to prevent certain potential sources of cross-contamination. 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.)