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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ed Vander Woude Dairy 11/14/13

  

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

Public Health Service
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
 
 
November 14, 2013                                                                                                               
                                                                                                                                                   WL # 2-14
Edward P. Vander Woude, Owner
Janice C. Vander Woude, Owner
Ed Vander Woude Dairy
36580 Ramona Expressway
San Jacinto, California 92582-2005
 
Dear Mr. and Mrs. Vander Woude,
 
On August 8, 2013 to September 23, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 36580 Ramona Expressway, 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 26, 2013, you sold a holstein cow, identified by (b)(4), Chino, California with back tag # (b)(4) for slaughter as food. On or about March 26, 2013, (b)(4) 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 sulfadimethoxine at (b)(4) parts per million (ppm) in the liver tissue. FDA has established a tolerance of 0.10 ppm for residues of sulfadimethoxine in the edible tissues of cattle as codified in Title 21, 556.640 (21 C.F.R. 556.640). The presence of this drug in edible tissues 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).Code of Federal Regulations (C.F.R.), Section
 
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).
 
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
            U.S. Food & Drug Administration
            19701 Fairchild
            Irvine, CA 92618
 
If you have any questions about the content of this letter please contact: Ms. Mariza M. Jafary, Compliance Officer, at (949) 608-2977.
 
Sincerely,
/S/
Steven Porter, Acting 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