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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Dream Farms 1/10/13

  

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 Stroots
Philadelphia, PA 19106
Telephone: 215-597-4390 

 

WARNING LETTER
13-PHI-08
 
 
January 10, 2013  
 
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
Allen W. Rice, Co-owner
Brian D. Brechbill, Co-owner
Dream Farms
13689 Dream Highway
Newburg, PA 17240
 
 
Dear Mr. Rice:
 
On November 21, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your heifer calf and cow raising farm operation located at 13689 Dream Highway, Newburg, PA. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act [the Act] that we found during our investigation of your operation. You can find the 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 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 Act, [21 U.S.C. § 360b]. Further, under section 402(a)(4) of the 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 January 9, 2012, you sold a heifer veal calf, identified with ear tag (b)(4), for slaughter as food. On or about January 11, 2012, (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 Tulathromycin. There is a zero tolerance for residues of Tulathromycin in the uncooked edible tissues of veal calves. The presence of this drug in edible tissues from this animal, cause the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the 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)].
 
The above is not intended to be an all-inclusive list of violations. As a grower 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 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/
Kirk D. Sooter
District Director
Philadelphia District
Enclosure(s):
  
 
cc:  
Brian D. Brechbill, Co-owner
Dream Farms
13689 Dream Highway
Newburg, PA 17240
 
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
 
Dr. David R. Griswold, Acting Director
Pennsylvania Department of Agriculture
Bureau of Animal Health and Diagnostic Services (BAHDS)
2301 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