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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

T & W Dairy 26-Jun-03

Department of Health and Human Services' logo

Public Health Service
Food and Drug Administration

  19900 MacArthur Blvd., Ste 300
Irvine, Caljfornia 92612-2445
Telephone (949) 798-7600



WARNING LETTER
June 26, 2003
CERTIFIED MAIL
RETURN RECEIPT REQUESTED W/L 42-03

Brian S. Wind
Partner
T & W Dairy
5459 Houghton Ave.
Bakersfield, CA 93313

Dear Mr. Wind:

Our records reflect that you are one of the partners of T & W Dairy located at 8545 Pine Street, Chino, CA. An investigation of your dairy operation conducted by our investigator on May 9-13, 2003, confirmed that you offered a cow for sale for slaughter
as food in violation of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug and Cosmetic Act ( “Act”). The inspection also revealed you caused an animal drug to become adulterated within the meaning of Section 501(a)(5) of the Act.

A food is adulterated under Section 402(a)(2)(C)(ii) of the Act if it contains a new animal drug that is unsafe within the meaning of Section 512 of the Act. A food is further adulterated under Section 402(a)(4) of the Act if it has been held under conditions
whereby it may have been rendered injurious to health.

On or about March 17, 2003, you sold a culled dairy cow identified by USDA Laboratory report 281302 for slaughter as human food. USDA analysis of tissue samples collected from that animal identified the presence of sulfadimethoxine in the liver at 8.55 parts per
million (ppm) and in the muscle at 7.94 ppm. A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in the edible tissues of cattle (Title 21, Code of Federal Regulations (CFR), Section 556.640). The presence of this drug at the level
reported in edible tissue from this animal causes the food to be adulterated with the meaning of Section 402(a)(2)(C)(G) of the Act.

Our investigation also found that you hold animals under improper conditions whereby diseased animals and/or medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you lack an adequate system for assuring
that animals medicated by you have been withheld from slaughter for the appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. Foods from animals held under such conditions are considered aduherated under
the Act.

It was further determined that you are using drugs in a manner contrary to their approved labeling. Specifically:

  • You are adulterating injectable penicillin, such as on dairy cattle, in a manner contrary to the approve labeled for intramuscular use at 1 ml. per hundred pounds of body weight. Your use of this drug as a topical spray for the treatment of pink-eye is not in agreement with the approved labeling.
  • You are adulterating oral sulfadimethoxine, such as hat you use on dairy cattle, in a manner contrary to the approved lab thoxine boluses are labeled with a 7 day meat withdrawal time. Your shipment of an animal within 4 days after treatment with sulfadimethoxine is not in agreement with the approved labeling.

Such extra-label use is not permitted, except by or on the lawful written or oral order of a licensed veterinarian within the context of a valid veterinarian-client-patient relationship, and otherwise in compliance with the limitations set forth for specific extra-label uses (21
CFR 530.10 and 530.11). Your use of drugs in any manner other than as labeled causes those drugs to be adulterated under Section 501 (a)(5) of the Act. Further, your use of this drug in dairy cows without following the labeled withdrawal period causes the
drug to be unsafe and, therefore, adulterated.

You should not consider this letter to be an all-inclusive list of violations existing at your facility. As a producer of animals offered for use as food, you are responsible for assuring that your overall operation and the foods that you distribute are in compliance with the law.

It is not necessary for you to have personally shipped an adulterated animal in interstate commerce to be responsible for a violation of the Act. The fact that you caused the adulteration of the animal that was subsequently offered for sale to a slaughterhouse
which ships in interstate commerce is sufficient to hold you responsible for a violation of the Act.

You should take prompt action to correct these violations and to establish procedures whereby such violations do not recur. Failure to achieve prompt corrective action may result in regulatory action being initiated by FDA without further informal notice. These
actions may include, but are not limited to, seizure and/or injunction. This letter constitutes official notification under the law and provides you an opportunity to correct.

Please notify this office in writing, within 15 working days of receipt of this letter, of the specific steps that you have taken to bring your firm into compliance with the law. Your response should include each step you have taken or will take to correct the violations
and to prevent the recurrence of similar violations. If corrective action cannot be taken within fifteen working days, state the reason for the delay and the time within which such corrections will be made. If you have any questions or need clarifications regarding this
letter prior to your written response, you may contact Barbara Rincon, Compliance Officer, at telephone number (949) 798-7739.

Your written response should be directed to:
Scott A. Goff
Acting Director, Compliance Branch
U.S. Food and Drug Administration
19900 MacArthur Blvd., Ste. 300
Irvine, CA 926 12-2445

Sincerely,
/s/

Alonza E. Cruse
District Director