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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Lone Star Calf Ranch, LP 6/18/12

  

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 

June 18, 2012
 

WARNING LETTER

2012-DAL-WL-24

UPS OVERNIGHT MAIL
 

Jake S. Tuls, Owner
Lone Star Calf Ranch, LP
4103 County Road E
Hereford, Texas 79045-8258

Dear Mr. Tuls:
 

On January 27, 28 and 30, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your calf raising operation located at 4103 County Road E, Hereford, 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 animals for slaughter as food that were 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.

Specifically, our investigation revealed that between October 20, 2011, and November 22, 2011, you sold the following five calves to (b)(4) for slaughter as food. On or about October 25 - November 22 , 2011, (b)(4) slaughtered these animals. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from these animals identified the presence of neomycin and sulfamethoxazole in the bob veal calves as noted in the chart below.
 

Calf Ear Tag#
Date sold to Americalf & slaughter
USDA case and Sample #
Value in ppm (parts per million)
(b)(4)
Sold 10/23/11 slaughtered: 10/25/11
Case # (b)(4) TX sample # (b)(4) On 11/15/11
Neomycin
Kidney (b)(4) ppm
(b)(4)
Sold 10/27/11 slaughtered: 10/28/11
Case # (b)(4) TX sample # (b)(4) On 11/15/11
Neomycin
Kidney (b)(4) ppm
Sulfamethoxazole
Liver (b)(4) ppm
Muscle (b)(4) ppm
(b)(4)
Sold 11/14/11 slaughtered: 11/17/11
Case # (b)(4) TX sample # (b)(4) On 12/07/11
Neomycin
Kidney (b)(4) ppm
(b)(4)
Sold 11/20/11 slaughtered: 11/22/11
Case # (b)(4) TX sample # (b)(4) On 12/14/11
Neomycin
Kidney (b)(4) ppm
(b)(4)
Sold 11/20/11 slaughtered: 11/22/11
Case # (b)(4) TX sample # (b)(4) On 1/12/12
Neomycin
Kidney (b)(4) ppm
 

The FDA has established a tolerance of (b)(4) ppm for residues of neomycin in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations, 556.430 (21 C.F.R. 556.430). However, this tolerance does not apply to use of NeoMed 325 ANADA 200-050 (neomycin sulfate) in bob veal calves (pre-ruminating calves). FDA has not established a tolerance for residues of sulfamethoxazole in the edible tissues of veal calves. There is no acceptable level of residue associated with the use of these drugs in veal calves. The presence of these drugs in ed ible tissues from these animals in the amounts noted above 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).

We also found that you adulterated the new animal drug NeoMed 325 ANADA 200-050 (neomycin sulfate) and the human drug Sulfamethoxazole and Trimethoprim (SMZ/TMP) Tablets, USP (NDA 53746-272-05). Specifically, our investigation revealed that you did not use NeoMed 325 and SMZ/TMP as directed by their approved labeling or veterinary prescription. Use of these drugs in this manner is an extralabel use. 21 C.F.R. § 530.3(a).

The extra label use of an approved animal or human drugs in animals are 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 NeoMed 325 and SMZ/TMP to bob veal calves without following the animal class or species as stated in the approved labeling or any directions by a licensed veterinarian. Your extralabel use of NeoMed 325 and SMZ/TMP was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11 (a) and your extra label use of NeoMed 325 and SMZ/TMP was in or on feed, in violation of 21 C.F.R. 530.11(b) and your extralabel use of NeoMed 325 and SMZ/TMP resulted in illegal residues, in violation of 21 C.F.R. 530.11(c). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs 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).

In addition, you adulterated both NeoMed 325 and SMZ/TMP within the meaning of section 501 (a)(6) of the FD&C Act, 21 U.S.C.§ 351 (a)(6), when you fed the unapproved combination of the medicated feed and human drug to your bob veal calves. Your feeding of this unapproved combination in this manner and not as directed by the approved labeling caused this medicated feed to be unsafe within the meaning of section 512 of the FD&C Act, 21 U.S.C. § 360b. Section 512 of the FD&C Act, 21 U.S.C. § 360b and 21 C.F.R. 530.11 (b) do not permit the extra label use of medicated feeds.

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.

Please, be advised that the addition of decoquinate to a medicated feed may result in an unapproved drug combination and will cause the medicated feed to be unsafe within the meaning of section 512 of the FD&C Act, 21 U.S.C. § 360b. Section 512 of the FD&C Act, 21 U.S.C. § 360b and 21 C.F.R. 530.11 (b) do not permit the extralabel use of medicated feeds.

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 Ronda Loyd-Jones, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Ste. 300, Dallas, Texas 75204. If you have any questions about this letter, please contact Compliance Officer Ronda Loyd-Jones at 214-253-5242.
 

Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
District Director