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  5. Faihopity Farms, LP - 07/31/2014
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Faihopity Farms, LP

Animal & Veterinary

Faihopity Farms, LP

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
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215·597·4390


July 31, 2014
Mrs. Elaine A. Broyan, Partner
Faihopity Farms, LP
492 Cemetery Road
Berwick, Pennsylvania 18603
Dear Mrs. Broyan:
On June 3, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm located at 492 Cemetery Road, Berwick, 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 17, 2014, you sold a bob veal calf, identified with sales/back tag (b)(4), for slaughter as food. On or about February 20, 2014, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from the bob veal calf with sales/back tag (b)(4) detected the presence of sulfadimethoxine in the kidney. FDA has established a tolerance of 0.1 parts per million (ppm) for residues of sulfadimethoxine in uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.640 (21 C.F.R. 556.640). However, this tolerance does not apply to use of Albon (sulfadimethoxine) NADA 31-715 in pre-ruminating veal calves, as there is no acceptable level of residue associated with Albon (sulfadimethoxine) NADA 31-715 in veal calves. The presence of this drug in edible tissue 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 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 drug Albon (sulfadimethoxine) (NADA 31-715). Specifically, our investigation revealed that you did not use Albon (sulfadimethoxine) as directed by its approved labeling. Use of this drug in this manner is an extralabel use, 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 Albon to bob veal calf identified with sales/back tag (b)(4) without following the animal class as stated in the approved labeling. Your extralabel use of Albon was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of Albon resulted in illegal drug residues 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.
Anne E. Johnson
Acting District Director
Philadelphia District Office
cc: Mr. Benedict Broyan, Partner
       Faihopity Farms, LP
       492 Cemetery Road
       Berwick, PA 18603
       Ms. Linda Broyan, Partner
       Faihopity Farms, LP
       492 Cemetery Road
       Berwick, PA 18603
       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

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