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  5. Hyland Acres Jerseys, Ltd. - 11/28/2014
  1. Compliance Actions and Activities

WARNING LETTER

Hyland Acres Jerseys, Ltd.

Product:
Animal & Veterinary

Recipient:
Hyland Acres Jerseys, Ltd.


United States

Issuing Office:
Cincinnati District Office

United States


   

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

Public Health Service
Food and Drug Administration
 
Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761 

 

November 28, 2014
 
Via United Parcel Service
WARNING LETTER
WL-15-444065-10
Ronald J. Kandel, Partner
Larry D. Alexander, Partner
Jerry Schonauer, Partner
Hyland Acres Jerseys Ltd.
5306 County Road 51
Big Prairie, Ohio  44611
 
Dear Messers. Kandel, Alexander, and Schonauer:
 
On September 22 and October 16, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 5306 County Road 51, Big Prairie, Ohio 44611. 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 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 June 4, 2014, you sold a bob veal calf, identified with back tag (b)(4) for slaughter as food.  On or about June 5, 2014, (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 20.99 parts per million (ppm) of neomycin in the kidney. FDA has established a tolerance of 7.2 ppm for residues of neomycin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.430 (21 C.F.R. § 556.430). However, this tolerance does not apply to the use of NeoMed 325 (Neomycin Sulfate, ANADA 200-050) Soluble Powder in calves to be processed for veal (pre-rumination calves), and there is no acceptable level of residue associated with the use of this drug in veal calves. The presence of this drug in edible tissue from this animal in this amount causes 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 complete treatment records and you failed to maintain drug inventory records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).
 
We also found that you adulterated the new animal drug NeoMed 325 Soluble Powder (Neomycin Sulfate, ANADA 200-050). Specifically, our investigation revealed that you did not use NeoMed 325 as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See 21 C.F.R. 530.3(a).
 
The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the 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 NeoMed 325 in a class of animal not set forth in the approved labeling. Your extralabel use of NeoMed 325 was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R.530.11(a) and your extralabel use of NeoMed 325 resulted in an illegal drug residue, in violation of 21 C.F.R.530.11(d). 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 Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the 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 Mark E. Parmon, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237. If you have any questions about this letter, please contact Compliance Officer Mark E. Parmon at (513) 679-2700, Ext. 2162 or at mark.parmon@fda.hhs.gov.
 
Sincerely yours,
/S/
Toniette K. Williams
Acting District Director
Cincinnati District
 
cc:     Dr. Tony Forshey, Chief
         Ohio Department of Agriculture
         Division of Animal Health
         8995 East Main Street
         Reynoldsburg, OH 43068-3399