• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

George Boere Dairy 5/9/13

  

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

Public Health Service
Food and Drug Administration
 Los Avngeles District
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4417 

 

WARNING LETTER
 
 
 
VIA UNITED PARCEL SERVICE                                                         
SIGNATURE REQUIRED
 
May 9, 2013
WL# 38-13
George E. Boere, Owner
George Boere Dairy
30490 Briggs Road
Menifee, California 92584-9594
 
Dear Mr. Boere:
 
On February 28, March 26, and April 10, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 30490 Briggs Rd, Menifee, 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 unsanitary conditions whereby it may have been rendered injurious to health.
 
Specifically, our investigation revealed that on or about December 19, 2012, you sold a cow, identified with ear tag # (b)(4) (house tag # (b)(4)) for slaughter as food. On or about December 19, 2013, American Beef Packers, Inc., Chino, California, 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 at 4.6 parts per million (ppm) in the kidney. The FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur 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 NADA 140-890 (ceftiofur). Specifically, our investigation revealed that you did not use Excenel RTU as directed by its approved labeling or veterinary prescription. 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 with ear tag (b)(4) (house tag # (b)(4)) without following the duration of the treatment as stated in its approved labeling or veterinary prescription. Excenel RTU is prohibited for extralabel used in cattle by 21 C.F.R. 530.41(a)(13) and your extralabel use of Excenel RTU resulted in an illegal drug residue in violation of 21 CFR 530.11(d). Because your use of Excenel RTU 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:
 
Blake Bevill
Director, Compliance Branch
U.S. Food and Drug Administration
19701 Fairchild
Irvine, California 92612
 
If you have any questions about this letter, please contact Compliance Officer Dr. Raymond W. Brullo at (949) 608-2918 or raymond.brullo@fda.hhs.gov. Include Identification Number: 3005236450 on all response correspondence.
 
Sincerely,
/S/
Alonza E. Cruse, Director
Los Angeles District
           
 
Cc:      
 
Hugo Cornejo, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue MS 7602
PO Box 997435
Sacramento, CA 95899-7435
Attn: FDA Correspondence
 
California Department of Food and Agriculture
Animal Health and Food Safety Services
Milk and Dairy Food Safety Branch
1220 N St.
Sacramento, CA 95814