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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ardounie Farms 6/6/13

  

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

 

 
WARNING LETTER
13-PHI-20
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
 
                                                                        June 6, 2013
 
 
Mrs. Loretta A. Duncan, Co-owner
Ardounie Farms
202 Bernville Road
Robesonia, Pennsylvania 19551
 
Dear Mrs. Duncan:
 
On May 6, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 202 Bernville Road, Robesonia, 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 February 13, 2013, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about February 14, 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 Flunixin in the kidney. FDA has not established a tolerance for residues of Flunixin in the edible tissues of veal calves. The presence of this drug in edible tissue(s) from this animal 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 for your calves. 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 Flu-nix-D (Flunixin Meglumine Injectable Sterile Solution, 50 mg/ml, ANADA #200-308). Specifically, our investigation revealed that you did not use Flu-nix-D as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See Title 21, Code of Federal Regulations (C.F.R.), 530.3(a) (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 Flu-nix-D to a bob veal calf, identified with back tag (b)(4), without following the animal class as stated in the labeling. Your extralabel use of Flu-nix-D was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of Flu-nix-D resulted in an illegal residue, in violation of 21 C.F.R. 530.11(c). 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).
 
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. Robin M. Rivers, 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. Rivers at (215)717-3076 or e-mail at robin.rivers@FDA.HHS.GOV.
 
                                                                        
Sincerely,
/S/ 
Kirk D. Sooter
District Director
Philadelphia District Office
 
 
cc: Mr. Donald B. Duncan, Co-owner
       Ardounie Farms
       202 Bernville Road
       Robesonia, Pennsylvania 19551
 
       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, Nebraska 68102