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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Double B Dairy, LLC 3/8/10

  

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

Public Health Service
Food and Drug Administration
 Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996

March 8, 2010

 


CERTIFIED MAIL
RETURN RECEIPT REQUESTED

 

 

 

In reply refer to Warning Letter SEA 10-17

Joseph F. Brasil, President and Partner
Double B Dairy, LLC
2930 South 2300 East
Wendell, Idaho 83355

WARNING LETTER

Dear Mr. Brasil:

On January 14, and 20, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 280 West 110 South, Murtaugh, Idaho. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.

We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to, be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

Specifically, our investigation revealed that on or about September 17, 2009, you sold a dairy cow, identified with Back Tag number (b)(4), for slaughter as food to (b)(4) where it was subsequently slaughtered on that same day. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of Flunixin at 1.494 parts per million (ppm) in the liver. FDA has established a tolerance of 0.125 ppm for residues of Flunixin in the edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.286 (21 C.F.R. 556.286).

The presence of Flunixin in edible tissues from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii).

Our investigation 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 records regarding the identity of animal(s) that you delivered for sale to (b)(4). Specifically, your treatment records are correlated to the numbered ear tags that you apply to the individual cows. On or about September 17, 2009, you sold seven cows for slaughter and removed the ear tags prior to them leaving your premises. You failed to correlate the ear tag numbers with back tag numbers, (b)(4) applied by (b)(4) when they picked up the cows and thereby lost the true identity of the cows and the ability to provide treatment records for those individual cows.

Additionally, you failed to have a system to control the administration of drug treatments to your animals. Specifically, it appears that the cow identified by back tag number (b)(4) was administered Banamine (Flunixin meglumine) and the treatment was never recorded. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).

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 violations described in this letter and to establish procedures to ensure that these violations do not recur. 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 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 of receiving this letter, 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 written response should be sent to Brenda L. Reihing, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you· have any questions about this letter, please contact Compliance Officer Reihing at (425) 483-4899.

Sincerely yours,

/s/

Charles M. Breen
District Director

 

cc: Luis Bettencourt, Vice President and Partner
Double B Dairy, LLC
2930 South 2300 East
Wendell, Idaho 83355