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WARNING LETTER

Hillcrest Homestead LLC MARCS-CMS 481772 — Nov 13, 2015

Hillcrest Homestead LLC - 481772 - 11/13/2015

Product:
Animal & Veterinary

Recipient:
Hillcrest Homestead LLC


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 
158-15 Liberty Avenue
Jamaica, NY 11433

 

November 13, 2015
 
WARNING LETTER NYK-2016-7
 
 
VIA UNITED POSTAL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Mr. Aaron P. Brooks, Co-Owner
Mrs. Catherine Brooks, Co-Owner
Hillcrest Homestead LLC
9020 Taylor Hill Road
Caneadea, New York 14717-8715
 
Dear Mr. and Mrs. Brooks:
 
On September 9, 2015 through September 21, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 9020 Taylor Hill Road, Caneadea, 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 the 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 June 29, 2015, you sold a calf identified with (b)(4), for slaughter as food. On or about June 30, 2015, (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 30.53 parts per million (ppm) of neomycin in the kidney tissue.  FDA has established a tolerance of 7.2 ppm for residues of neomycin in uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (CFR), Section 556.430(b)(1) (21 C.F.R. 556.430(b)(1)). However, this tolerance does not apply to the use of neomycin in calves to be processed for veal (pre-ruminant 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 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 Vet One Neomycin (Neomycin Sulfate Liquid, ANADA 200-379). Specifically, our investigation revealed that you did not use Vet One Neomycin as directed by its approved labeling. Use of this drug in this manner is an extra-label use. See 21 C.F.R. 530.3(a).
 
The extra-label use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extra-label 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 Vet One Neomycin to a calf identified with (b)(4) without following the animal class as stated in the approved labeling. Your extra-label use of Vet One Neomycin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). In addition, your extra-label use of Vet One Neomycin was in or on feed, in violation of 21 C.F.R. 530.11(b) and 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 the approved labeling and did not comply with 21 CFR 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).
 
In addition, you adulterated the animal feed that you fed your bob veal calf identified with (b)(4) by adding the new animal drug Vet One Neomycin to the milk, within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6). The extralabel use of drugs in or on animal feed is specifically prohibited by section 512(a)(4), 21 U.S.C. § 360b(a)(4), of the FD&C Act, and 21 C.F.R. Part 530.11(b).
 
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 CDR 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 Compliance Officer Frank Verni at (718) 662-5702 or by e-mail at frank.verni@fda.hhs.gov.
 
 
Sincerely,
/S/ 
Ronald M. Pace
District Director
New York District

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