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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Veldhuis North Dairy 15-Oct-07

Department of Health and Human Services' logoDepartment of Health and 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

Our Reference: 3006374501

October 15, 2007

Ray Veldhuis, Owner
Eric Veldhuis, General Manager
Veldhuis North Dairy
12465 Lee Road
Ballico, California 95303

WARNING LETTER

Dear Messrs Veldhuis:

An inspection of your dairy operation located at 12465 Lee Road, Ballico, California, conducted by are preventative of the U.S. Food & Drug Administration (FDA) on July 18, 23 and 26, 2007, confirmed that you offered art animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and its associated regulations on the internet through links on the FDA's web page at www.fda.gov.

On January 23, 2007, you consigned a dairy cow, identified with back tag number [redacted] for slaughter at [redacted]. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of sulfadirnethoxine in the liver at 0.35 parts per million (ppm) and in the muscle at 0.13 ppm. A tolerance level for residues of sulfadimethoxine has been established for the uncooked edible tissues of cattle at 0.1 ppm as codified in Title 21, Code of Federal Regulations, section 556.640 (21 C.F.R. § 556.640). The presence of this drug in the tissues of this cow in these amounts causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] of the Act.

Our inspection also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain complete treatment records that contain the amount of the drug you used, the route it was administered and the withdrawal time. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Act."

The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law. You should take prompt action to correct the above violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.

Your firm has a history of offering cattle for sale for human food use that contain above-tolerance levels of antibiotic residues. According to USDA reports, during the period of January 12, 200[redacted] through January 23, 200[redacted], your firm delivered [redacted] cows with illegal drug residues. Under contract with FDA, the State of California conducted inspections of your dairy an March 20, 2002, February 7, 2003, and May 12, 2005, in follow up to [redacted] of those illegal residues. At the conclusion of each of those State of California inspections, your firm was issued Notices of Warning for each of the illegal drug residues.

We have enclosed an amended version of the FDA-483 issued to you at the close of our inspection.

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter, Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason far the delay and the time frame within which the corrections will be completed, Please include copies of any available documentation demonstrating that corrections have been made.

Your written response should be directed to Karen L. Robles, Consumer Safety Officer, Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding this letter, please contact Karen Robles at (916) 930-3674, ext. 114.

Sincerely,

/S/

Barbara J. Cassens
District Director
San Francisco District