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WARNING LETTER

Ontario Ranch Holsteins

Product:
Animal & Veterinary

Recipient:
Ontario Ranch Holsteins


United States

Issuing Office:
Los Angeles District Office

United States


   

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

Food and Drug Administration
 
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4415 

 

WARNING LETTER
                                                                       
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED  
 
February 25, 2014
 
WL # 15-14
 
Rudy U. Haringa, Owner
Rudy Haringa, Sr., Former Co-Owner
Ontario Ranch Holsteins
14848 Grove Ave
Ontario, California 91710
 
Dear Messrs. Haringa:
 
On November 5 and December 6, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 14848 Grove Avenue, Ontario, 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 July 19, 2013, you sold a dairy cow, identified with ear tag (b)(4) and back tag (b)(4) for slaughter as food. On or about July 19, 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 0.5 parts per million (ppm) in the kidney tissue. FDA has established a tolerance of 0.4 ppm for residues of ceftiofur in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 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 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 drug, Excenel RTU (desfuroylceftiofur, NADA 140-890). Specifically, our investigation revealed that you did not use Excenel RTU 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 Excenel RTU to a dairy cow identified with ear tag (b)(4) without following the withdrawal period as stated in the approved labeling. Your extralabel use of Excenel RTU was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of Excenel RTU 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 dealer 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. 
 
Our investigation also revealed that on or about July 19, 2013, Mr. Rudy U. Haringa provided to Euclid Stockyards, Inc., a State of California Bill of Sale or Consignment that states that the animals presented for slaughter do not have an illegal level of drug residues. On or about July 19, 2013, you delivered a dairy cow identified with ear tag (b)(4), which contained violative residues of desfuroylceftiofur, to (b)(4). Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. § 331(h). You should take appropriate actions to ensure that this violation does not recur.
 
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. Reference FEI: 3000203005 in all correspondence.
 
Your written response should be sent to:
 
Blake Bevill, Director
Compliance Branch
U.S. Food and Drug Administration
19701 Fairchild
Irvine, CA 92612
 
If you have any questions about this letter, please contact Dr. Raymond W. Brullo at (949) 608-2918.
 
 
Sincerely,
/s/ 
Alonza E. Cruse, Director
Los Angeles District