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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Vos Dairy, Inc. 08-Jan-02

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Seattle District

Pacific Region

22201 23rd Drive SE

Bothell, WA 98021-4421

Telephone: 425-486-8788

FAX; 425-483-4996

January 8, 2002

VIA CERTIFIED MAIL

RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 02-27

WARNING LETTER

Alger H. Vos, President

Vos Dairy, Inc.

20028 127th Ave. NE

Arlington, Washington 98223

Dear Mr. Vos:

An investigation at your dairy located at 20028 127th Ave. NE, Arlington, Washington, by our investigator on December 11 and 14, 2001, confirmed that you offered animals for sale for slaughter as food in violation of Section 402(a) (2)( C)(ii), and 402(a)(4) 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 of the Act. On or about, August 14, 2001, you sold a culled dairy cow, back tag #91 MS 1011, identified on USDA-FSIS Lab Form #411326. This cow was sold for slaughter as human food to

USDA analysis of tissue sample from the cow with back tag # 81 NS 1011 identified the

presence of tylosin at 8.95 parts per million (PPM) in the kidney, well over the maximum residue level of 0.2 PPM in the kidney.

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 conditions on your farm:

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.

2. You lack an adequate system for assuring that drugs are used in a manner not contrary to the directions contained in their labeling.

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 into interstate commerce to be responsible for a violation of the Act. The fact that you offered an adulterated animal to be slaughtered into food for human consumption where it was held for sale in interstate commerce is sufficient to make you responsible for violations of the Act.

Please respond within fifteen (15 ) days of the receipt of this letter, notify this office in writing 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.

Please send your reply to the Food and Drug Administration, Attention: Bruce Williamson, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. [f you have questions regarding any issue in this letter, please contact Bruce Williamson, Compliance Officer, (425) 483-4976.

Sincerely,

Charles M. Breen

District Director