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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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O & L Dairy #2 02-Jul-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

 

Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda. CA 94502-7070
Telephone: 510-337-6700

Via Federal Express
WARNING LETTER
Our Reference: 2956392
July 2, 2001

John S. Leal, Partner
AdeIino Ormonde, Partner
Edward Ormonde, Partner
O & L Dairy #2
13051 Avenue 200
Tulare, CA 93274

Dear Messrs. Leal and Ormonde:

Tissue residue reports from the United States Department of Agriculture (USDA) and an investigation of your dairy on February 21 and 22, and on June 6, 2001 by the Food and Drug Administration (FDA) have revealed serious violations of the Federal Food, Drug, and Cosmetic Act (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. On January 8,2001, you consigned a cow, identified with back tag number 93 EZ 6334 (USDA laboratory report number 418976), for slaughter as human food. USDA analysis of tissue samples collected from that animal identified the presence of the drug penicillin in the liver at 0.12 parts per million (ppm), in the muscle at 00.72 ppm, and in the kidney at 23.60 ppm. On May 7, 2001, you consigned a cow, identified with back tag number 93 EZ 5563 (USDA laboratory report number 419054), for slaughter as human food. USDA analysis of tissue samples collected from that animal identified the presence of the drug penicillin in the kidney at 0.72 ppm in the kidney. A tolerance has been established for residues of penicillin in the edible tissues of cattle at 0.05 ppm.

A food is adulterated under Section 402(a)(4) of the Act "if it has been prepared, packed, or held under insanitary conditions... whereby it may have been rendered injurious to health. " As it applies in this case, "insanitary conditions" means that you hold animals which are ultimately offered for sale for slaughter as food under conditions which are so inadequate that medicated animals bearing possibly harmful drug residues are likely to enter the food supply. For example, our investigator noted the following:

You lack an adequate system for determining the medication status of animals you offer for slaughter. Your medication records are not permanent and do not contain the drug and dosage administered and the individual performing the medication of each animal at your dairy.

You lack an adequate system for assuring that animals to which you administer medication have been withheld from slaughter for appropriate periods of time to deplete potentially hazardous residues of drugs.

You lack an adequate system for assuring that drugs are used in a manner not contrary to the directions contained in their labeling or your veterinarian?s prescription? labeling. You lack an adequate system for assuring animals have been treated only with drugs which have been approved for use in their class of animal or species.

You lack an adequate inventory system for determining the quantities of drugs used to medicate your cows and calves. Failure to comply with the label instructions on drugs you use to treat your cows and calves presents the likely possibility that illegal residues will occur and makes the drugs unsafe for use. We request that you take prompt action to ensure that animals which you offer for sale as human food will not be adulterated with drugs or contain illegal residues.

Introducing adulterated foods into interstate commerce is a violation of Section 301(a) of the Act. Causing the adulteration of drugs after receipt in interstate commerce is a violation of Section 301(k) of the Act.

You should be aware that 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 offered an adulterated animal for sale to a slaughter facility where it was held for sale in interstate commerce is sufficient to make you responsible for violations of theAct. This is not intended to be an all-inclusive list of violations. It is your responsibility to ensure that all requirements of the Act are being met. Failure to achieve prompt corrections may result in enforcement action without further notice, including seizure and/or injunction.

You should notify this office in writing, within fifteen(15) working days of the receipt of this letter, of the specific steps you have taken to correct these violations and preclude their recurrence. If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which corrections will be completed. Your response should address each discrepancy brought to your attention during the inspection and in this letter, and should include copies of any documentation demonstrating that corrections have been made. Please direct your reply to Suzanne Schenck, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94502.

Sincerely,

/s/
Dennis K. Linsley
District Director