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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Echeverria Dairy 06-Feb-03

Department of Health and Human ServicesDepartment of Health and Human Services            Public Health Service


Food and Drug Administration

19900 MacArthur Blvd., Ste 300

Irvine, California 92612-2445

Telephone (949) 798-7600

WARNING LETTER

February 6, 2003

CERTIFIED MAIL

RETURN RECEIPT REQUESTED W/L 21-03

Juan I. Echeverria

Owner

Echeverria Dairy

8762 Kimball Ave.

Chino, CA 91710

Dear Mr. Echeverria:

An investigation at your dairy operation located at 8762 Kimball Ave., Chino California, conducted by our investigators on December 10-11, 2002, confirmed that you offered animals 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 (henceforth the "Act"), and you caused a new animal drug to become adulterated within the meaning of Section 501(a)(5).

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 adulterated under Section 402(a)(4) of the Act if the food has been held under insanitary conditions whereby it may have been rendered injurious to health. As it applies in this instance, "insanitary conditions," refers to your lack of records for animals which you medicate.

Consequently, you held an animal, which was ultimately offered for sale for human food, under conditions which are so inadequate that a medicated animal bearing potentially harmful drug residues was likely to enter the food supply.

On or about September 23, 2002, you sold a culled dairy cow identified by USDA Laboratory report 265727 for slaughter as human food. USDA analysis of tissue samples collected from that animal identified the presence of penicillin in the kidney at 0.94 parts per million (ppm) and 0.43 ppm in the liver. A tolerance of 0.05 ppm has been established for residues of penicillin in the edible tissues of cattle.

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 adulterated.

Please note that it is not necessary for you to personally ship an adulterated animal in interstate commerce to be responsible for a violation of the Act. The fact that you caused the adulteration of an animal that was sold to a slaughterhouse which ships in interstate commerce is sufficient to hold you responsible for a violation of the Act.

A drug is adulterated under Section 501(a)(5) of the Act if it is administered in a manner other than in accordance with the directions specified in the labeling, thereby making it unsafe within the meaning of Section 512(a)(1)(B). You are adulterating the drug [redacted] that your dairy uses on cattle, when it is used as was indicated to our investigators, in a manner contrary to the approved labeling. [redacted] is labeled for administration of 1 cc per hundred pounds of body weight. Your administration of 15 ccs to a 1300 pound cow is not in accordance with the approved labeling.

While a licensed veterinarian, under certain well-defined circumstances, may administer or prescribe drugs in a manner not approved in the labeling, such authority has not been extended to non-veterinarians under any circumstances.

The above is not intended to be an all-inclusive list of violations. Government records available to us indicate there have been other occasions when you have offered drug adulterated animals for sale as human food. As a producer of animals which are offered for use as food, you are responsible for assuring that your overall operations and the food you distribute are in compliance with the law.

You should take prompt action to correct the above violations and to assure that the procedures you have established will prevent their recurrence. Failure to do so may result in regulatory action, such as injunction, without further notice. This letter constitutes official notification under the law and provides you an opportunity to correct.

Please advise this office in writing within fifteen (15) working days of receipt of this letter of the steps you have taken to bring your dairy into compliance with the law. Your response should include each step that has been taken to correct the violations and prevent their recurrence. If corrective action cannot be taken within fifteen (15) 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:

Acting Director, Compliance Branch

U.S. Food and Drug Administration

19900 MacArthur Blvd., Ste. 300

Irvine, CA 92612-2445

Sincerely,

/s/

Alonza E. Cruse

District Director