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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Dan Dee Dairy, LLC 23-Oct-07

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

Public Health Service
Food and Drug Administration

 

Denver District Office
Southwest Region
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


 

October 23, 2007

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Jason A. Flores
Owner
Dan Dee Dairy, LLC.
181 East Darby Road
Dexter, NM 88230-9722

Ref.#: DEN-08-06

Dear Mr. Flores:

An investigation of your dairy operation located at 181 East Darby Road, Dexter, New Mexico, conducted by a representative of the U.S. Food and Drug Administration (FDA) on June 19 - 20, 2007, confirmed that you offered an 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, 21 U.S.C. §§ 301 et seq. (the "Act"). The inspection also revealed that you caused the new animal drug Flunixin to become adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)] and unsafe under section 512 of the Act [21 U.S.C § 360b]. 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 November 28, 2006, you sold a dairy cow, identified with ear tag [redacted] for slaughter as food. The animal was slaughtered by [redacted]. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 1.06 parts per million (ppm) Flunixin in the liver tissue A tolerance of 0.125 ppm has been established for residues of Flunixin in the liver tissue of cattle., as codified in Title 21, Code of Federal Regulations, Section 556.286 [21 C.F.R. § 556.286]. The presence of this drug in the edible tissues of this animal in amounts exceeding the tolerance set out in 21 C.F.R. § 556.286 causes the food to be adulterated within the me aning 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 and review complete treatment records prior to sale for slaughter. Food from animals held under such conditions are adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)].

In addition, you adulterated Flunixin within the meaning of section 501(a)(5) [21 U.S.C. § 351 (a)(5)] of the Act when you failed to use the drugs in conformance with their approved labeling. "Extra-label use," which is the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, see 21 C.F.R. § 530.3(a), is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian-client-patient relationship and in compliance with the requirements of 21 C.F.R. Part 530. The extra-label use of approved veterinary or human drugs must comply with sections 512(a)(4)and (5) of the Act [21 U.S.C. §§ 360b(a)(4),(5)] and 21 C.F.R. Part 530.

You, however, administered Flunixin without following the withdrawal period set forth in the approved labeling, and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a). Furthermore, your extra-label use resulted in illegal drug residue, in violation of 21 C.F.R. § 530.11(c). Because your extra-label use of this drug did not comply with 21 C.F.R. Part 530, the drug was unsafe under section 512(a) of the Act [21 U.S.C. § 360b(a)], and your use caused it to be adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C.§ 351(a)(5)].

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 foods you distribute are 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.

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 for the delay and the time frame within which the corrections will be completed. Please include with your response copies of any documentation demonstrating that corrections have been made.

Your response should be sent to U.S. Food and Drug Administration, P.O. Box 25087, Denver, Colorado 80225-0087, Attention: William H. Sherer, Compliance Officer. If you have any questions about this letter, please contact Mr. Sherer at (303) 236-3051.

Sincerely,

/S/

B. Belinda Collins Denver
District Director
 

cc:
Ronald C. Nelson, D.V.M.
Denver District Director
USDA/FSIS
PO Box 25387
DFC, Bldg 25
Denver, CO 80225

I. Miley Gonzalez, Ph.D.
Secretary
New Mexico Department of Agriculture
New Mexico State University
P.O. Box 300005, MSC 3189
Las Cruces, NM 88003-8005
Lee C. Jan, D.V.M.

Director
Texas Department of Health
Meat Safety Assurance Unit
1100 West: 49th Street
Austin, TX 78756-7466