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WARNING LETTER

Swiss Hill Farm Nov 20, 2015

Swiss Hill Farm - 11/20/2015

Product:
Animal & Veterinary

Recipient:
Swiss Hill Farm


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 20, 2015
 
WARNING LETTER NYK-2016-10
 
 
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Mr. Richard David Fitch, Co-Owner
Mrs. Robin Fitch, Co-Owner
Swiss Hill Farm
147 Millers Mills Road
West Winfield, New York 13491-2607
 
Dear Mr. and Mrs. Fitch:
 
On September 25 and 29, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 147 Millers Mills Road, West Winfield, 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 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. 
 
Specifically, our investigation revealed that on or about May 13, 2015, you sold a bob veal calf, identified with back tag (b)(4) and New York State ear tag (b)(4), for slaughter as food. On or about May 15, 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 neomycin at 13.06 parts per million (ppm) in the kidney. 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 (C.F.R.), Section 556.430 (21 C.F.R. 556.430). However, this tolerance does not apply to the use of (b)(4) 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 tissues 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).
 
We also found that you adulterated the drug (b)(4). Specifically, our investigation revealed that you did not use (b)(4) 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 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) to a bob veal calf with ear tag (b)(4) without following the animal class as stated in the approved labeling.   Your extralabel use of (b)(4) was 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 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).
 
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 the medicated milk replacer in conformance with its approved labeling. Your use of this medicated milk replacer 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 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 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:       Mr. Justin D. Fitch, Herdsman
            Swiss Hill Farm
            147 Millers Mills Road
            West Winfield, New York 13491-2607
           
            S. McGlashan, D.V.M.
            Cherry Valley Veterinary Associates
            4896 US Highway 20
            Springfield Center, New York 13468
 
            E. Schoene, D.V.M
            Cherry Valley Veterinary Associates
            4896 US Highway 20
            Springfield Center, New York 13468