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U.S. Department of Health and Human Services

Animal & Veterinary

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Regulatory Activities – July and August 2008

Warning Letters
FDA Veterinarian Newsletter May / June 2008 Volume XXIII, No III

The Food and Drug Administration has sent a WARNING LETTER to Wayne R. Mathis, managing partner of Mathis Ranch, d/b/a Texas Legend Ranch, Kendalia, TX, for violations of the adulteration provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). Specifically, the ranch sold a goat for slaughter as food that was found to contain 0.0577 parts per million (ppm) moxidectin in the liver tissue and 0.0161 ppm moxidectin in the muscle tissue. Because no toler-ance for residues of this drug in the edible tissues of goats has been established by FDA, the animal was found to be adulterated within the meaning of Section 402(a) of the FFDCA. The firm was also found to have adulterated moxidectin (Cydectin) within the meaning of Section 501(a) of the FFDCA for failing to use it in conformance with its approved label-ing. Also, FDA’s extralabel use requirements set forth in 21 Code of Federal Regulations (CFR) 530 with respect to mox-idectin were violated, and use of the drug was found to be unsafe within the meaning of Section 512(a) of the FFDCA.

Todd Simmons, president and chief executive officer of Simmons Pet Food, Inc., Siloam Springs, AR, has received a WARNING LETTER for serious deviations from the Low-Acid Canned Food Regulations described in CFR Parts 108 (Emergency Permit Control) and 113 (Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Contain-ers). Specific violations included the following: the firm has not established a product traffic control system to prevent un-retorted product from bypassing the retort process (21 CFR 113.87(b)); the firm’s container cooling water was not chlorin-ated or otherwise sanitized as necessary for cooling canals and recirculated water supplies (21 CFR 113.60(b)); the firm failed to record all process deviations involving a failure to satisfy the minimum requirements of the scheduled process, as well as the actions taken by the firm to either fully re-process or set aside and evaluate that portion of the production in-volved in the process deviations (21 CFR 113.89); and the firm’s recording thermometer charts and container closure re-cords were not adequately reviewed by representatives of plant management (21 CFR 113.100(b) and (c)).

Recalls

A Class II firm-initiated recall is ongoing by Pfizer Inc. of Canada, Kirkland, Canada, for 1,441 50-blus bottles of Neo-Sulfalyte neomycin/sulfamethazine/electrolyte bolus. The products, which were distributed only within Canada, were re-called due to low potency for neomycin.

Land O’Lakes Purina Feed LLC, Statesville, NC, is conducting a firm-initiated Class III recall of 13,522 50-lb. bags of horse feed because of the presence of aflatoxin in the feed at unacceptable levels. The products were distributed in North Carolina, South Carolina, Virginia, and West Virginia.

A total of 154,313 units of Dr. Turtle Medication Block Card and Medication Bulk are the subject of an ongoing, firm-initiated Class III recall by Aquatrol, Inc., Anaheim, CA. The recall is being conducted because the products may not con-tain the specified level of sulfathiazole ingredient indicated on the labeling. Distribution took place nationwide and in Guam.