• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Circle T Dairy 6/22/09

  

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

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3145

June 22, 2009


Ref: 2009-DAL-WL-14


WARNING LETTER


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Mr. Jim te Velde, Owner
Circle T. Dairy
5427 US Hwy 385
Hereford, Texas 79045


Dear Mr. te Velde:


On March 5, 6 and 9, 2009 and May 5, 2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 5427 US Hwy 385, Hereford, Texas. 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 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 December 10, 2008, you consigned for sale a dairy cow, identified with your farm ear flap tag (b)(4) for slaughter as food. On or about December 12, 2008, (b)(4), Texas, slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDAIFSIS) analysis of tissue samples collected from this animal identified the presence of flunixin at 0.475 parts per million (ppm) in liver tissue. FDA has established a tolerance of 0.125 ppm in liver tissue as codified in Title 21, Code of Federal Regulations, Section 556.286(b)(1) [21 CFR 556.286(b)(1)).

The presence of this drug in edible tissue 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. For example, you failed to maintain complete treatment records. 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).

We also found that you adulterated the new animal drug flunixin meglumine. Specifically, our investigation revealed that you did not use flunixin meglumine as directed by its approved labeling. Use of this drug in this manner is an extralabel use under 21 CFR 530.3(a).

The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 CFR Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. 

Our investigation found that you administered flunixin meglumine injection to a dairy cow without following the withdrawal period for meat in cattle as stated in the approved labeling, that is, four (4) days from the last day of treatment. Your extralabel use of flunixin meglumine was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11 (a). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 CFR Part 530, you caused the drug to be unsafe under section 512(a) of the Act, 21 U.S.C. § 360b(a), and 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 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.

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 copies of any available documentation demonstrating that corrections have been made.

Your written response should be sent to Edwin Ramos, Compliance Officer, U.S. Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about this letter, please contact Compliance Officer Ramos at 214-253-5218.


Sincerely yours,

 

Reynaldo R. Rodriguez, Jr.
District Director
Dallas District


Enclosure(s): 21 C.F.R. 556.286
21 C.F.R. Part 530


cc:


Mr. Donald A. te Velde, Herdsman
5427 US Hwy 385
Hereford, TX 79045


Howard Johnson, DVM
Texas Department of State Health Services
Environmental and Consumer Safety Section
Meat Safety Assurance Unit
1100 W. 49th Street
Austin, TX 78756


James Kyle, DVM
USDA-FSIS, Technical Service Center
Landmark Center, Suite 300
1299 Farnam Street
Omaha, NE 68102

 

(b)(4)