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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Hilltop Jersey Farm 7/5/13

  

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 75204-3128 

 

July 5, 2013
 
Ref: 2013-DAL-WL-040
 
WARNING LETTER
 
UPS OVERNIGHT MAIL
                                                                                                     
Nico J. De Boer, Owner
Hilltop Jersey Farm
19008 FM 3079
Chandler, Texas 75758
 
Dear Mr. De Boer:
 
On March 19 and 25, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 19008 FM 3079, Chandler, Texas. 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 November 26, 2012, you sold a bob veal calf, identified with ear tag (b)(4) and back tag (b)(4), for slaughter as food. On or about November 27, 2012, (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 sulfamethoxazole in the kidney. FDA has not established a tolerance for residues of sulfamethoxazole in calves to be processed for veal. 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 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 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 human drug Sulfamethoxazole and Trimethoprim (b)(4) Tablets, USP, (b)(4). Specifically, our investigation revealed that you did not use Sulfamethoxazole and Trimethoprim (b)(4) Tablets, USP, (b)(4), as directed by its approved labeling or by your servicing veterinarian’s prescription.  Use of these drugs in this manner is an extralabel use as defined under Title 21, Code of Federal Regulations (C.F.R.), Section 530.3(a) (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 Sulfamethoxazole and Trimethoprim (b)(4) Tablets, USP, (b)(4), to a bob veal calf, identified with ear tag (b)(4) and back tag (b)(4), without following the withdrawal period as prescribed by one of your servicing veterinarians. Your extralabel use of Sulfamethoxazole and Trimethoprim (b)(4) Tablets, USP, (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 Sulfamethoxazole and Trimethoprim (b)(4) Tablets, USP, (b)(4), resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). 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. 
 
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 Thao Ta, 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 Mr. Ta at 214-253-5217.
 
Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
Dallas District Director
 
 
 
cc:    FSIS District Office 40
         Attn:  Dr. Jennifer Beasley-McKean, D.V.M
         1100 Commerce Street, Room 516
         Dallas, Texas 75242-0598
 
         Texas Department of State Health Services
         1100 W. 49th Street
         Austin, Texas 78756