- Leroy B. Horst Jr.
- Issuing Office:
- New York District Office
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, NY 11433
March 9, 2015
WARNING LETTER NYK-2015-25
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Leroy B. Horst, Junior, Owner
7660 State Route 90N
Cayuga, New York 13034
Dear Mr. Horst:
On January 15and 22, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 7660 State Route 90N, Cayuga, 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. 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 (b)(4), you sold a dairy cow, identified with NY State Metal Tag #(b)(4), for slaughter as food. On or about (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 0.26 parts per million (ppm) of ampicillin in the kidney. FDA has established a tolerance of 0.01 ppm for residues of ampicillin in the uncooked edible tissues of cattle codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.40 (21 C.F.R. 556.40). The presence of this drug in edible tissue from this animal 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 held expired drugs in your drug inventory. 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 (b)(4) (Ampicillin, NADA (b)(4)) and (b)(4)(Tetracycline HCL, ANDA (b)(4)). Specifically, our investigation revealed that you did not use (b)(4) and (b)(4) as directed by their approved labeling or veterinary prescription. Use of these drugs 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 the new animal drug (b)(4) to a dairy cow identified with NY State Metal Tag #(b)(4), without following the indication for use as set forth in the approved product labeling. Also, our investigation found that you administer (b)(4) to your cows without following the route of administration and indication for use as stated in the approved labeling. Your extralabel use of (b)(4) and (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of (b)(4) resulted in illegal residues, in violation of 21 C.F.R. 530.11(d). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the 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).
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.
In addition, we noted in your signed affidavit that you are feeding colostrum to young calves from cows you treated with (b)(4) (Cephapirin Benzathine, NADA (b)(4)). The approved label for (b)(4) advises that milk from treated cows must not be used for food during the first 72 hours after calving. The extralabel use of a drug via feed is prohibited by 21 CFR 530(b).
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 Kristen Jackson, 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 LCDR Kristen Jackson at (718) 662-5711 or email at firstname.lastname@example.org.
Ronald M. Pace
New York District