Inspections, Compliance, Enforcement, and Criminal Investigations

Van Kooten Dairy 10/8/15

  

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

Public Health Service
Food and Drug Administration
 Dallas District Office
4040 North Central Expressway
Suite 300
Dallas, Texas 75204-3128

 

October 8, 2015
 
2015-DAL-WL-34
Warning Letter
 
UPS Overnight
           
 
Gerardus G. Van Kooten, Owner
Van Kooten Dairy
3200 Highway 1689
Comanche, Texas 76442-5208
 
Dear Mr. Van Kooten:
 
On July 28 and 29, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 3200 Highway 1689, Comanche, Texas 76442-5208. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C 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 FD&C 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 FD&C Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the FD&C 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 March 20, 2015, you sold a dairy cow identified with farm ear tag # (b)(4) and back tag #(b)(4) (along with an additional ear tag #(b)(4) and a carcass tag #(b)(4)), for slaughter as food. On or about March 20, 2015, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 34.7 parts per million (ppm) of oxytetracycline in the kidney tissue and the presence of 5.48 ppm of flunixin residue in the liver tissue. FDA has established a tolerance of 12.0 ppm for residues of oxytetracycline in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.500 (21 C.F.R. 556.500) and a tolerance of 0.125 ppm for residues of flunixin in the liver (target tissue) of cattle as codified in 21 C.F.R. 556.286. The presence of these drugs in edible tissues from this animal in these amounts causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C 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 FD&C Act, 21 U.S.C. 342(a)(4).
 
We also found that you adulterated the new animal drugs (b)(4), ANADA (b)(4)) and (b)(4) sterile injectable solution ((b)(4), ANADA (b)(4)). Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling and/or by the veterinarian’s prescription. Use of these drugs in this manner is an extralabel use. See 21 C.F.R. 530.3(a).
 
The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. 360b(a)(4) and (5), and 21 C.F.R. 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 (b)(4), ANADA (b)(4)) to a dairy cow identified with farm ear tag #(b)(4) and back tag #(b)(4), without following the meat withdrawal period set forth in the approved drug labeling. Your extralabel use of the (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a), and  your extralabel use of (b)(4) resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).
 
Our investigation also found that you administered (b)(4), ANADA (b)(4)) to the same dairy cow identified with farm ear tag #(b)(4) and back tag #(b)(4), without following the route of administration and the meat withdrawal period set forth in the approved labeling. Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a), and your extralabel use of (b)(4) resulted in an illegal drug residue, in violation of 21 C.F.R.530.11(d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C 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 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. 
 
FDA acknowledges receipt of your letter dated August 1, 2015, sent in response to the Form FDA 483, dated July 29, 2015. However, this response is not adequate for the following reasons. You stated your intentions to use an adapted version of the dairy treatment record provided by the Investigator during the inspection. However, you did not provide evidence showing what changes to the record are being made. Further, your response does not address any process changes to prevent animals from being sold for slaughter before the appropriate withdrawal period has been observed.
 
Our investigations also revealed that on March 20, 2015, you provided to (b)(4), a signed certification stating that the livestock you sell do not have illegal levels of drug residues. On March 20, 2015, you delivered a cow identified with ear tag #(b)(4) and back tag #(b)(4), which contained violative residues of oxytetracycline and flunixin, to (b)(4). Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. 301(h). You should take appropriate actions to ensure that this violation does not reoccur.
 
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 Mr. Jeffrey R. Wooley, 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 Jeffrey R. Wooley (214) 253-5251.
 
 
Sincerely,
/S/ 
Reynaldo R. Rodriguez, Jr.
Dallas District Director
 
cc:    FSIS District Office 40
         Attn: Dr. Jennifer Beasely-McKean, DM
         1100 Commerce Street, Room 516
         Dallas, Texas 75242-0598
 
         Texas Department of State Health Services
         1100 W. 49th Street
         Austin, Texas 78756
 
         Comanche Veterinary Clinic
         Attn: Dr. Randall D. Abbey, DVM
         1306 W. Central Avenue
         Comanche, Texas 76442

Page Last Updated: 12/04/2015
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