• 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

Section Contents Menu

Enforcement Actions

R & J Haringa Dairy 7/17/13

  

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 

 

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
WARNING LETTER
 
 
July 17, 2013       
                                                                                                                    WL # 48-13
 
Mr. Ronald W. Haringa, Owner
R & J Haringa Dairy
38980 Record Road
San Jacinto, California 92583
 
Dear Mr. Haringa:
 
On May 15 and 17, 2013 and June 4 and 7, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 38980 Record Road, San Jacinto, 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 March 19, 2013, you sold a dairy cow, identified by (b)(4) with back tag (b)(4) for slaughter as food. On or about March 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 penicillin at 0.075 parts per million (ppm) in the kidney tissue. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the 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. 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 drugs (b)(4) (Penicillin G Procaine Injectable Suspension, (b)(4) and (b)(4) (Ceftiofur Hydrochloride Sterile Suspension (b)(4)). Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs 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 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 routinely administer 20 mL of (b)(4) per day for a period of three days for crippled cows. According to the approved labeling, the dosage for dairy cattle is 1 mL per 100 pounds of body weight. The cow identified with back tag # (b)(4), weighed 1,240 lbs. Per the approved labeling, the therapeutic dosage should be 12.4 mL per day. In addition, the use of Penicillin G Procaine to treat “crippled cows” is not in conformance with the drug’s approved labeling. Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). 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).
 
Our investigation also found that you administered (b)(4) (Ceftiofur Hydrochloride Sterile Suspension, (b)(4)) to your dairy cows without following the duration of treatment as stated in the approved labeling. Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). In addition (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 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).
 
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 response should be sent to:
 
Mr. Blake Bevill
Director, Compliance Branch
Food and Drug Administration
19701 Fairchild
Irvine, California 92612-2506
 
Refer to the Unique Identification Number CMS case # 406273 when replying. If you have any questions about this letter please contact: Dr. William Vitale at 949-608-2919.
 
 
Sincerely,
/S/ 
Alonza E. Cruse, Director
Los Angeles District
 
 
Cc:     
Julie Haringa, Owner
R & J Haringa Dairy
38980 Record Road
San Jacinto, California 92583
 
Dr. Robert Sheffield
33748 Milan Road
Winchester, California 92596
 
Hugo Cornejo, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue MS 7602
PO Box 997435
Sacramento, California 95899-7435