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  1. Warning Letters

WARNING LETTER

Zubrzycki Homestead

Product:
Animal & Veterinary

Recipient:
Zubrzycki Homestead


United States

Issuing Office:
New York District Office

United States


   

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

Public Health Service
Food and Drug Administration
 
New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433  

 

January 22, 2014
 
WARNING LETTER NYK-2014-16
 
VIA UNITED POSTAL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Mr. Mark S. Zubrzycki, Co-Owner
Mr. John W. Zubrzycki, Co-Owner
Mrs. Mary E. Zubrzycki, Co-Owner
Zubrzycki Homestead
7799 State Route 12
Lowville, New York 13367
 
Dear Messer’s and Mrs. Zubrzycki:
 
During November 5 through November 13, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 7799 State Route 12, Lowville, New York. 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 two animals for slaughter as food that were 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 March 7, 2013, you sold a bob veal calf, identified with ear tag (b)(4), for slaughter as food. On or about March 8, 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 13.86 parts per million (ppm) of neomycin residue in the kidney.  Additionally, our investigation revealed that on or about July 11, 2013, you sold a bob veal calf, identified with ear tags (b)(4) and (b)(4), for slaughter as food. On or about July 12, 2013, (b)(4), slaughtered this animal.  USDA/FSIS analysis of tissue samples collected from this animal identified the presence of 11.07 ppm of neomycin residue in the kidney.  FDA has established a tolerance of 7.2 ppm for residues of neomycin in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (CFR), Section 556.430 (21 CFR 556.430). However, this tolerance does not apply to the use of (b)(4) (containing Neomycin Sulfate and Oxytetracycline) 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 these animals in these amounts 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 and to segregate treated 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).
 
We also found that you adulterated the new animal drugs neomycin sulfate and oxytetracycline contained in (b)(4). Specifically, our investigation revealed that you did not use neomycin sulfate and oxytetracycline as directed by the medicated feed approved labeling. Use of these drugs in this manner is an extralabel use. See 21 CFR 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 Act, 21 U.S.C. § 360b(a)(4) and (5) and 21 CFR 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 neomycin sulfate and oxytetracycline to bob veal calves without following the animal class as stated in the approved labeling. Your extralabel use of neomycin sulfate and oxytetracycline resulted in an illegal residue, in violation of 21 CFR 530.11(c). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 CFR Part 530, you caused these drugs 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).
 
In addition, you adulterated (b)(4) within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6), when you failed to use this medicated feed in conformance with its approved labeling. Your use of this medicated feed without following the animal class as directed by the approved labeling caused this medicated feed to be unsafe within the meaning of section 512 of the FD&C Act, 21 U.S.C. § 360b. Section 512 of the FD&C Act, 21 U.S.C. § 360b and 21 CFR 530.11(b) do not permit the extralabel use of medicated feed.
 
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 are 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 LCDR Frank Verni, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have any questions about this letter, please contact LCDR Frank Verni, Compliance Officer at (718) 662-5702 or by email at frank.verni@fda.hhs.gov.
 
 
Sincerely yours,
/S/
Ronald M. Pace
District Director
New York District