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  5. Holmes Acre LLC - 06/10/2015
  1. Warning Letters

WARNING LETTER

Holmes Acre LLC

Product:
Animal & Veterinary

Recipient:
Holmes Acre 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 

 

June 10, 2015
 
WARNING LETTER NYK-2015-35 
 
 
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Mr. Peter L. Holmes, Member of LLC
Holmes Acre LLC
2876 East Road
New Woodstock, New York 13122-9730
 
Dear Mr. Holmes:
 
On March 16 and 25, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 2876 East Road, New Woodstock, New York 13122-9730. 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 November 19, 2014, you sold a bob veal calf, identified with ear tags # (b)(4), for slaughter as food. On or about November 19, 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 8.38 parts per million (ppm) of neomycin residue in the kidney. In addition, our investigation revealed that on or about January 6, 2015, you sold a bob veal calf, identified with ear tags #(b)(4), for slaughter as food. On or about January 6, 2015, (b)(4), slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of 10.77 parts per million (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 (C.F.R.), 556.430 (21 C.F.R. 556.430). However, this tolerance does not apply to the use of (b)(4) in bob veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with the use of the drug (neomycin) in bob veal calves (pre-ruminating calves). The presence of neomycin in edible tissues from these animals in the amounts stated 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 you failed to identify animals that you transported and offered for sale. 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 hydrochloride found in (b)(4), lasalocid found in (b)(4), and (b)(4). Specifically, our investigation revealed that you did not use (b)(4) as directed by their approved labeling or veterinary prescriptions. Use of these drugs in this manner is an extra-label use. See 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 (b)(4) replacer containing neomycin sulfate (1600.0 grams/ton) and oxytetracycline hydrochloride (1600.0 grams/ton), to a class of animals (veal calf with ear tags #(b)(4) and veal calf with ear tags #(b)(4) not set forth in the approved labeling. Also, our investigation found that you administered (b)(4), to a class of animals, veal calves, not set forth in the approved labeling. Our investigation also found that you administered (b)(4) to cow (b)(4) for a longer period of time than specified in the labeling. Your extralabel use of (b)(4) were not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use of (b)(4) resulted in an illegal drug residue, in violation of 21 C.F.R.530.11(c). Because your use of these drugs were not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused these drugs 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).
 
In addition, you adulterated (b)(4) containing neomycin sulfate (1600.0 grams/ton) and oxytetracycline hydrochloride (1600.0 grams/ton) and (b)(4)(containing lasalocid), 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 these medicated milk replacers in conformance with their approved labeling. Your use of these medicated milk replacers without following the animal class as directed by the approved labeling caused this medicated supplement 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 C.F.R. 530.11(b) do not permit the extra-label 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 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 LCDR Catherine M. Beer, Compliance Officer, U.S. Food and Drug Administration, 1 Winners Circle, Suite 110, Albany, New York 12205. If you have any questions about this letter, please contact Compliance Officer Catherine M. Beer at (518) 453-2314 x1015 or Email at Catherine.Beer@fda.hhs.gov.
 
Sincerely yours,
/S/ 
Ronald M. Pace
District Director
New York District
 
 
cc:        William Johnson, D.V.M.
            117 County Highway
            New Berlin, New York 13411
 
            Dr. David Smith, Director (redacted copy)
            Division of Animal Industry
            New York State Department of Agriculture & Markets
            10 B Airline Drive
            Albany, New York 12235
 
            Mr. Jesse M. Holmes, Member LLC
            Holmes Acre LLC
            2876 East Road
            New Woodstock, New York 13122-9730
 
            Mr. Jim Holmes, Member LLC
            Holmes Acre LLC
            2876 East Road
            New Woodstock, New York 13122-9730