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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

4-Way Dairy, LLC 4/12/13

  

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

Public Health Service
Food and Drug Administration
 Denver District Office
Building 20 - Denver Federal Center
P.O. Box 25087
Denver, Colorado 80225-0087
TELEPHONE: 303-236-3000 

 

April 12, 2013
 
WARNING LETTER
 
 
VIA UPS Overnight
 
Mr. Callen D. Mitchell, Co-Owner
4-Way Dairy, LLC
493 New Mexico 467
Portales, NM 88130
Ref: # DEN-13-12-WL
Dear Mr. Mitchell:
 
On January 7 – 10, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm located at 493 New Mexico 467, Portales, New Mexico 88130. 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 July 13, 2012, you sold a dairy cow, identified with ear bangle tag (b)(4), for slaughter as food. On or about July 19, 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 0.14 parts per million (ppm) of penicillin in the kidney tissue. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.510, 21 C.F.R. 556.510. 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 complete treatment records and review said records to verify applicable withdrawal time prior to offering the animal for slaughter as food. 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 drug (b)(4). Specifically, our investigation revealed that you did not use (b)(4) as directed by its approved labeling. Use of this drug 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) to a dairy cow, identified with ear bangle tag (b)(4), without following the withdrawal period as stated on the approved labeling. Your extra label 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.
 
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 Sarah A. Della Fave, Compliance Officer, U.S. Food and Drug Administration, 6th Avenue & Kipling Street – Building 20 DFC, P.O. Box 25087, Denver, Colorado 80225-0087. If you have any questions about this letter, please contact Compliance Officer Sarah A. Della Fave at (303) 236-3006 or email at Sarah.Dellafave@fda.hhs.gov.
 
 
Sincerely yours,
/S/
LaTonya Mitchell
District Director
Denver District
 
cc:      
Ms. Demarys L. Mitchell
4-Way Dairy, LLC
93 New Mexico 467
Portales, NM 88130
 
Mr. Ronnie Mitchell
4-Way Dairy, LLC
93 New Mexico 467
Portales, NM 88130
 
Ms. Sybil Mitchell
4-Way Dairy, LLC
93 New Mexico 467
Portales, NM 88130
 
Ronald K. Jones, D.V.M.
Denver District Manager
USDA/FSIS
PO Box 25387
DFC, Bldg 45
Denver, CO 80225
 
Mr. Jeff M. Witte, Secretary
New Mexico Department of Agriculture
New Mexico State University
P.O. Box 300005, MSC 3189
Las Cruces, NM 88003-8005
 
Howard Johnson, D.V.M., Director
Texas Department of State Health Services
Meat Safety Assurance Unit, MC 1872
8407 Wall Street
P. O. Box 149347
Austin, Texas 78714-9347