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  5. Zylstra Dairy Farms, Inc. - 04/15/2015
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WARNING LETTER

Zylstra Dairy Farms, Inc. Apr 15, 2015

Zylstra Dairy Farms, Inc. - 04/15/2015

Product:
Animal & Veterinary

Recipient:
Zylstra Dairy Farms, Inc.


United States

Issuing Office:
Philadelphia District Office

United States


   

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

Public Health Service
Food and Drug Administration
  PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19105
Telephone: 215-597-4390

 

WARNING LETTER
15-PHI-14
 
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
April 15, 2015
 
 
Mr. Andrew S. Zylstra, President
Zylstra Dairy Farm
1161 Greiger Road
Friedens, PA 15541
 
Dear Mr. Zylstra:
 
On January 7, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm located at 1161 Greiger Road, Friedens, Pennsylvania. 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 April 4, 2014, you sold a dairy cow, identified with back tag #(b)(4), and farm tag #(b)(4) for slaughter as food. On or about April 4, 2014 (b)(4) slaughtered this animal. USDA testing detected a flunixin residue of 0.304 parts per million (ppm). FDA has established a tolerance of 0.125 parts per million (ppm) for residues of flunixin in the uncooked edible liver tissues of cattle, as codified in Title 21, Code of Federal Regulations, Section 21 CFR 556.286(b)(1)(i).
 
Therefore, the presence of these drugs in the edible tissue from these animals cause 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 identify and segregate animals. 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 written response should be sent to Ms. Yvette Johnson, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Ms. Johnson at (215)717-3077 or e-mail at Yvette.Johnson@fda.hhs.gov.
  
Sincerely,
/S/ 
Anne E. Johnson
Acting District Director
Philadelphia District Office 
      
cc: Dr. David R. Griswold, Acting Director
       Pennsylvania Department of Agriculture
       Bureau of Animal Health and Diagnostic Services (BAHDS)
       2301 North Cameron Street
       Harrisburg, Pennsylvania 17120
 
       Dr. Thomas Alexander
       Chief of Regulation and Compliance
       Pennsylvania Department of Agriculture
       Bureau of Animal Health
       Room 408
       2301 North Cameron Street        
       Harrisburg, Pennsylvania 17110
 
       Dr. Isabel Arrington, Director TA/C
       United States Department of Agriculture (USDA)
       Food Safety and Inspection Service (FSIS)
       Office of Policy and Program Development
       1616 Capitol Avenue, Suite 260
       Omaha, NE 68102

 

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