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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Sierra Vista Dairy 23-Jun-03

Department of Health and Human Services' logo

Public Health Service
Food and Drug Administration

  San Francisco District
1431 Harbor Bay Parkway
Alamkia. CA 94602-7070
Telephone: 510-337-6700


Via Federal Exnress
Our Reference: 1000123745

June 23, 2003

Pete J. VanderPoel, Owner
Sierra Vista Dairy
15434 Avenua 192
Tulare, CA 93274

WARNING LETTER

Dear Mr. VanderPoel:


A tissue residue report received by the Food and Drug Administration (FDA) from the United States Department of Agriculture (USDA) reported the presence of an illegal drug residue in a cow that originated from your dairy. As a follow-up to USDA’s finding, our investigators performed an inspection of your dairy operation April 29 & 30, 2003. This inspection revealed serious violations of Sections 402(a)(2)(C)(ii), 402(a)(4) and 501(a)(5) of the Federal Food, Drug, and Cosmetic Act (the Act). .

On February 18, 2003, you sold a dairy cow, identified with ear tag # 1004 and subsequently identified with [redacted] back tag number 2411, last four digits, for slaughter as human food. USDA analysis of tissue samples (USDA labaratory report number 441845) collected hrn that animal identified the presence of the drug penicillin in the kidney at 0.17 parts per million (ppm). Presently, the tolerance level for penicillin in the uncooked edible tissue of cattle is 0.05 ppm (Title 21 Code of Federal
Regulations (CFR), Part 556.510). Your use of penicillin in the animal resulted in the illegal drug residue found in the kidney. 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.

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 investigators noted the following:

1. 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. The veterinarian’s prescription for
Pen-Aqueous brand penicillin G specifies that the animal be withheld from slaughter for 18 days. You were observing only a 10 day withdrawal period.

2. You lack an adequate system for assuring that drugs are used in a manner consistent with the directions contained in their labeling or your veterinarian’s prescription labeling. In addition to failure to follow the withdrawals times, you failed to follow
the veterinarian’s prescription for Pen-Aqueous brand penicillin G of a maximum dose of 10cc in any one site.

3. You lack an adequate inventory/accountability system for determining the quantities of drugs used to medicate your cows and calves.

You are adulterating Pen-Aqueous brand penicillin G within the meaning of Section 501(a)(5) of the Act, in that it is a new animal drug within Section 201(v) of the Act, and is unsafe within the meaning of Section 512(a)(1)(B) of the Act since it is not being used
in conformance with its approved labeling. Your veterinarian prescribes, and the manufacturer’s label specifies, a maximum dosage of 10cc per site. Your practice of injecting 15cc at one site results in a dosage in excess of that allowed in the labeling. This overdosing presents a possibility that illegal residues will occur.

Failure to comply with the label instructions on drugs you use to treat your animals 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 the Act.

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 our 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 Russell A. Campbell, Compliance Officer, United States Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502.

Sincerely,

/s/

Dennis K. Linsley

District Director
San Francisco District