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U.S. Department of Health and Human Services

Animal & Veterinary

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Regulatory Activities - November/December 2005

FDA Veterinarian Newsletter November/December 2005 Volume XX, No VI

A Warning Letter was issued to Jerry N. Meissner, president, Norm-E-Lane, Inc., Chili, WI, because an investigation confirmed that the dairy operation offered a dairy cow for sale for slaughter as food that was adulterated because of the presence of the new animal drugs sulfadimethoxine and penicillin G procaine in excess of the tolerances set forth in 21 CFR 556.640 and 21 CFR 556.510. The inspection also revealed that these new animal drugs were caused to be adulterated and unsafe. The investigation also found that the facility held animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. The operation lacked an adequate system to ensure that medicated animals were withheld from slaughter for the appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, the dairy operation lacked an adequate monitoring system to ensure that medications are administered to the designated animal. Food from animal held under such conditions is adulterated.

A Warning Letter was issued to Steven J. Silver, president, International Nutrition, Inc., Omaha, NE, because an investigation of the medicated feed mill and drug manufacturing site found a significant deviation from the Current Good Manufacturing Practice (cGMP) regulations for medicated feeds. Such a deviation causes the feed being manufactured at this facility to be adulterated. The investigation found that the firm failed to implement adequate safeguards to prevent unsafe contamination in the production of feeds. A calf vitamin/mineral product was manufactured following the production of a Category II, Type B medicated feed, Carbadox. An analysis of a Food and Drug Administration (FDA) sample found 170 ppm and 25 ppm in two of the 10 sub (samples) collected during the investigation. Carbadox is not approved for use in cattle feed. Also, Arsanilic Acid 4.5g/lb. was manufactured by sequencing after Arsanilic Acid 90g/lb. Assay of Arsanilic Acid 4.5g/lb. found it to be 131 percent, which is outside of the allowable assay limits of 85-115 percent. The investigation into the cause of the out-of-limits assay concluded carryover from the production of the Arsanilic Acid 90g/lb. was a likely cause. In addition, several labeling deviations were observed that cause certain feed products manufactured by the firm to be adulterated. Product labels for ZINPRO Corporation products containing the statement “Manufactured By ZINPRO Corporation” when the products are manufactured by International Nutrition Inc. for ZINPRO Corporation was observed. Also, the distribution of Type A medicated articles to consignees from whom the firm did not obtain an unrevoked written statement caused the new animal drug to be deemed unsafe and, thus, adulterated. In addition, the investigation found that labels for feeds containing procaine penicillin and decoquinate, for use in poultry laying hens and sheep, respectively, are not in conformance with the approved new animal drug applications. The approval for procaine penicillin provides that feed be labeled with a warning against use in poultry laying eggs for human consumption. The approval for decoquinate provides that feed be labeled with a warning against use in sheep producing milk for food. Labeling these products without the required warning statements causes these feeds to be unsafe and, thus, adulterated. It was also determined that the firm has not maintained in its possession the New Animal Drug Application approved labels as required by 21 CFR 510.305.