Inspections, Compliance, Enforcement, and Criminal Investigations

James A. Gilligan 10/19/15

  

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

October 19, 2015

 
WARNING LETTER NYK-2015-3
 
 
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Mr. James A. Gilligan, Co-Owner
Mrs. Deanne L. Gilligan, Co-Owner
Bellewood Farms
7592 Lake Road
Woodville, New York 13650-2023
 
Dear Mr. & Mrs. Gilligan.:
 
On August 25 and September 1, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 7592 Lake Road, Woodville, 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 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 11, 2015, you sold a bob veal calf, identified with New York State Metal ear tag (b)(4) and sale tag #(b)(4), for slaughter as food. On or about June 12, 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 9.1 parts per million (ppm) of neomycin residue in the kidney. FDA has established a tolerance of 7.2 parts per million (ppm) for residues of neomycin in the uncooked edible kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.430(b)(1) (21 C.F.R. 556.430(b)(1)).  However, this tolerance does not apply to the use of (b)(4) containing neomycin sulfate and oxytetracycline hydrochloride in veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with the use of (b)(4) containing neomycin sulfate and oxytetracycline hydrochloride in veal calves (pre-ruminating calves).  Therefore, the presence of this drug in kidney 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 drugs (b)(4) (neomycin sulfate and oxytetracycline hydrochloride), (b)(4) (ceftiofur sodium, NADA (b)(4)), (b)(4) (ampicillin, NADA (b)(4)), (b)(4) (flunixin meglumine, NADA (b)(4)), and (b)(4) (penicillin G procaine, NADA (b)(4)). Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling. 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 (b)(4) to a bob veal calf identified with New York State Metal ear tag #(b)(4) and sale tag # (b)(4) without following the animal class as stated in the approved labeling. Your extra-label use of (b)(4) 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 (b)(4) was in or on feed, in violation of 21 C.F.R. 530.11(b) and resulted in illegal residues, in violation of 21 C.F.R. 530.11(c). 
 
Our investigation also found that you administered (b)(4) to your heifer calves without following the dosage as stated in the approved labeling. Certain uses of ceftiofur (e.g. unapproved doses) are prohibited for extralabel use in cattle by 21 C.F.R. 530.41(a)(13)(ii).
 
Also, our investigation found that you administered (b)(4) to your cows without following the indications for use and to your heifer calves without following the dose 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).
 
In addition, our investigation found that you administered (b)(4) to your heifer calves without following the route of administration 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, our investigation found that you administered (b)(4) to your cows without following the indication for use and the injection amount per site 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).
 
Because your use of these drugs was not in conformance with the 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) medicated feed 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 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 under 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.
 
We received a written response dated September 4, 2015, from (b)(4), which included a letter promising that your firm would address and correct each observation on the Form FDA 483. This response was not adequate, as there was no supporting documentation to indicate what actions have been implemented, or plan to be implemented, to ensure that lasting corrective actions are being implemented.
 
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 C. 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 LCDR Kristen Jackson at (718) 662-5711 or Email at Kristen.Jackson@fda.hhs.gov.
 
 
Sincerely yours,
/S/
Ronald M. Pace
District Director
New York District
 

Page Last Updated: 10/26/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.