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U.S. Department of Health and Human Services

Animal & Veterinary

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August - September Regulatory Activities

FDA Veterinarian Newsletter 2007 Volume XXII, No IV

Warning Letters

Significant deviations from the Food and Drug Administration’s Current Good Manufacturing Practice (cGMP) Regulations for Medicated Feeds has led to the issuance of a WARNING LETTER to John A. Rickman, president of Farmers Market of Bolivar, Missouri, in Bolivar, MO. Such deviations caused medicated feeds being manufactured at this facility to be adulterated within the meaning of section 501(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA). Specifically, FDA’s inspection of the facility revealed the following: (1) A failure to document the investigations and any corrective actions taken as a result of out-of-specification assay results. For example, in 2006, medicated feeds pyrantel tartrate/carbadox, nicarbazin, amprolium were not within permissible assay limits and no investigation and correction actions, including discontinuing distribution of the out of specification medicated feeds, were taken. (2) A failure to have a Master Record File for the manufacturing of all products. For example, either no Master Record File existed or the file was created after the medicated feed was manufactured. (3) A failure to maintain complete production record(s). For example, the production records often failed to identify that the feed was a medicated feed.

FDA issued a WARNING LETTER to William P. Rogers, owner of the Rogers Farm in Warren, MA, for offering a cow for slaughter as food that was adulterated within the meaning of section 402(a) of the FFDCA. Tissue samples collected by the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) revealed the presence of gentamicin in the kidney tissue. No tolerance has been established for residues of gentamicin in the uncooked edible tissues of cattle. FDA’s investigations also revealed that the firm held animals under conditions that were so inadequate that medicated animals bearing potentially harmful drug residues were likely to enter the food supply. Mr. Rogers also lacked an adequate system to ensure that medicated animals had been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. In addition, Mr. Rogers adulterated gentamicin sulfate within the meaning of section 501(a) of the FFDCA when he failed to use the drug in conformance with its approved labeling. Other violations included providing a false guaranty in violation of section 301(h) of the FFDCA.

A WARNING LETTER has been issued to Ross A. Tappan, general manager of the Arizona Dairy Company, LLP, Mesa, AZ, for violations of the adulteration provisions in sections 402(a) and 501(a) of the FFDCA. Specifically, this dairy operation sold a culled dairy cow for slaughter as human food to a broker/hauler. An analysis of tissues samples by FSIS revealed the presence of penicillin at 0.64 parts per million (ppm) in the kidney, 0.08 ppm in the liver, and 1.08 ppm in the muscle tissue. FDA has set a tolerance of 0.05 ppm for residues of penicillin in the edible tissues of cattle (21 CFR 556.510). In addition, the FSIS analysis revealed the presence of flunixin in the liver tissue at 3.70 ppm. FDA has set a tolerance for this drug of 0.125 ppm in the liver tissue of cattle (21 CFR 556.286). A second animal was sold for slaughter, and the FSIS analysis of tissue samples collected from that animal identified the presence of flunixin at 0.235 ppm in the liver. A tolerance of 0.125 ppm has been established for residues of flunixin in the liver tissue of cattle as codified in 21 CFR 556.286. A third animal was also sold to a broker/hauler, and this animal contained sulfadimethoxine at 0.17 ppm in the liver and 0.14 ppm in the muscle tissue. A tolerance 0.1 ppm has been established by FDA for residues of this drug in the edible tissues of cattle (21 CFR 556.640). Flunixin was also found at 0.14 ppm in the liver and at 0.083 ppm in the muscle tissue. A tolerance of 0.125 ppm and 0.025 ppm has been established for residues of flunixin in the liver and muscle tissue of cattle, respectively, as codified in 21 CFR 556.286. These excessive amounts of the drugs caused all three animals to be adulterated under section 402(a) of the FFDCA. In addition, the firm’s extralabel use of penicillin G procaine and flunixin meglumine was not in compliance with 21 CFR Part 530, rendering them adulterated under section 501(a) of the FFDCA.

Recalls

A Class I firm-initiated recall is ongoing by Mars Petcare USA of Brentwood, TN, for 1,176 bags of its 55-lb. Ol’ Roy Complete Nutrition Dry Dog Food. The reason for the recall is that the product may be contaminated with Salmonella. The recalled products were distributed in Virginia, Maryland, North Carolina, Pennsylvania, West Virginia, and Ohio.

Petraport, Inc., of North Bergen, NJ, is in the process of conducting a Class I recall of 132,640 bags of Beefeaters Brand and Berkley & Jensen bulk units of pig ear dog treats that may be contaminated with Salmonella. Distribution of the products, which were manufactured by Graneles de Chile S.A., of Rancagua, Chile, took place nationwide.

Alltech, Inc., of Nicholasville, KY, is carrying out a Class III recall of various types of its feed premix packaged in 25-lb. bags. The recall was begun because Bioplex Copper 10%, a feed premix, and premixes containing Bioplex Copper, were made using copper sulfate pentahydrate that was contaminated with dioxin-like polychlorinated biphenyls. Distribution of the 147,785 kg of products took place nationwide and internationally.