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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Superior Cattle Feeders LLC 8/20/14

  

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

Public Health Service
Food and Drug Administration
 
Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax            (949) 608-4415

 

                                                                                                                                                                                         
CERTIFIED MAIL
RETURN RECEIPT REQUESTED                                                                    
 
 
August 20, 2014                                                                                                        
W/L # 34-14
 
Mr. Robert A. Lofton, Partner and Co-Owner
Mr. Dominique Antchagno, Partner and Co-Owner 
Superior Cattle Feeders, LLC
P.O. Box 1828
Calipatria, California 92233
 
Dear Messers. Lofton and Antchagno:
 
On June 5, 12, and 18, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your farm located at 6050 U.S. Highway 111, Calipatria, California. 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 December 26, 2013, you sold a steer, identified with (b)(4), for slaughter as food. On or about December 26, 2013, (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 desfuroylceftiofur (marker residue for ceftiofur) at 86.48 parts per million (ppm) in the kidney tissue. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in the kidney (target tissue) of cattle as codified in Title 21, 556.113(b)(3)(i) (21 C.F.R. 556.113(b)(3)(i)). 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. 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 you adulterated the new animal drug (b)(4) (ceftiofur hydrochloride) Injectable Sterile Suspension, (b)(4). Specifically, you did not use (b)(4) (ceftiofur hydrochloride) Injectable Sterile Suspension, (b)(4), as directed by its approved labeling or by your servicing veterinarian’s written prescription. Use of this drug in this manner is an extralabel use, as described in 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 you administered (b)(4) (ceftiofur hydrochloride) Injectable Sterile Suspension, (b)(4), to a steer, identified with ear tags (b)(4), without following the dose and withdrawal period as stated in the approved labeling and as prescribed by your servicing veterinarian. Your extralabel use of (b)(4) (ceftiofur hydrochloride) Injectable Sterile Suspension, (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) (ceftiofur hydrochloride) Injectable Sterile Suspension, (b)(4), resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d).  In addition, (b)(4) (ceftiofur hydrochloride) Injectable Sterile Suspension, (b)(4), is prohibited for extralabel use in cattle by 21 C.F.R. 530.41(a)(13)(ii). Because your use of this drug was not in conformance with its approved labeling and your servicing veterinarian’s written prescription 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 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 these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction. 
 
We acknowledge that on or about January 23, 2014, your servicing veterinarian, (b)(6), provided training to your firm’s staff for the prevention of antibiotic residues in cattle offered for sale by your farm.  We cannot verify this corrective action for effectiveness at this time.
 
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 response should be sent to:
 
Acting Director, Compliance Branch
Food and Drug Administration
19701 Fairchild
Irvine, California 92612-2506
 
If you have questions regarding any issues in this letter, please contact Dr. William S. (Bill) Vitale, Compliance Officer, at 949-608-2919.
 
 
Sincerely,
/S/
Alonza E. Cruse
District Director
Los Angeles District
 
cc:     
Harlan Loui, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
Sacramento, California 95899-7413
 
Annette Whiteford-Jones, DVM
State Veterinarian and Director
California Department of Food and Agriculture
1220 N Street
Sacramento, CA 95814
 
 
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