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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Epicenter Dairy 26-Feb-04

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Southwest Region
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
Telephone: 303-236-3000
FAX: 303-236-3100

 

February 26, 2004

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REOUESTED

Mr. Kevin Finnerty
Epicenter Dairy
5159 Silver Mnt. Way
Alta Loma, CA 91737

Ref. #: DEN-04-06

Dear Mr. Finnerty:

Consumer Safety Officer Michael L. Zimmerman conducted an inspection of your dairy operation, Epicenter Dairy, 250 Navajo, Hagerman, NM on November 17-19, 2003. The inspection 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 (the Act), and that you may have caused animal drugs to become adulterated within the meaning of section 501(a)(5) of 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. You sold dairy cows on two separate occasions to [redacted] which were found to contain illegal levels of drug residues by USDA testing.

These two incidents, recorded under USDA case No. 03-0675-NM include:

May 29, 2003: USDA analysis of tissue samples collected from your dairy cow with ear tag 3795 (USDA Sample No. 416006) identified the presence of sulfadimethoxine residue of 1.13 ppm in the liver and 0.56 ppm in the muscle. A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in the uncooked edible tissues of cattle in 21 CFR 556.640.

July 7, 2003: USDA analysis of tissue samples collected from your dairy cow with ear tag 778 (USDA Sample No. 416008) identified the presence of sulfadimethoxine residue of 2.63 ppm in the liver and 4.33 ppm in the muscle.

During our investigation, you indicated that your firm treated these animals with [redacted] (Sulfadimethoxine) [redacted]. The presence of this drug in uncooked edible tissue from these animals in amounts exceeding the tolerance set out in 21 CFR 556.640 causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act.

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, animal treatment records are missing or incomplete, and you lack an adequate system for assuring 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.

In addition, you are adulterating the drug sulfadimethoxine that your firm uses on dairy cows when you fail to use the drug in conformance with its approved labeling. Your use of the drug without following the labeled withdrawal period causes the drug to be unsafe for use within the meaning of Section 512(a) of the Act and thus adulterated under Section 501(a)(5) of the Act.

As a producer of animals offered for use as food, you are responsible for assuring that your overall operation and the foods you distribute are in compliance with the law. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.

You should notify this office in writing, within 15 working days of receipt of this letter, of the steps you have taken to correct these violations and preclude; their recurrence. If corrective action cannot be completed within 15 working days, state the reason for 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 response should be sent to H. Tom Warwick, Compliance Officer, Food and Drug Administration, P.O. Box 25087, Denver, Colorado, 80225-0087. He may be reached at (303) 236-3054 if you have any questions about this matter.

Sincerely,

/s/

B. Belinda Collins
District Director