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  5. Alex Jackson and Wayne Jackson - 02/05/2014
  1. Warning Letters

WARNING LETTER

Alex Jackson and Wayne Jackson

Product:
Animal & Veterinary

Recipient:
Alex Jackson and Wayne Jackson


United States

Issuing Office:
New England District Office

United States


   

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
Fax 781.587.7556
 
 
WARNING LETTER
CMS # 419448
 
 
Via United Parcel Service
 
February 5, 2014
 
Alex Jackson, Owner
Wayne Jackson, Owner
114 Overlock Hill Road
Union, Maine 04862
 
Dear Messrs. Jackson:
 
On December 16 & 20, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 114 Overlock Hill Road, Union, Maine. 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 February 4, 2013, you sold a bob veal calf, identified with ear tag # (b)(4) for slaughter as food. On or about February 7, 2013, (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 flunixin in the kidney tissue. FDA has not established a tolerance for residues of flunixin in the edible tissues of preruminating 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).
 
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 treatment records, you failed to segregate treated animals and you lack an adequate inventory system for determining the quantities of drugs used to medicate your animals. 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) (flunixin injection) (b)(4), Furosemide Injection 5% (b)(4), (b)(4) (florfenicol) (b)(4), (b)(4) (ceftiofur crystalline free acid) (b)(4), (b)(4) (oxytetracycline) (b)(4), and Penicillin G Procaine (b)(4). Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling or by your servicing veterinarian’s prescription. Use of these drugs in this manner is an extralabel use. See Title 21, Code of Federal Regulations (C.F.R.), 530.3(a) (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 calf identified 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), and your extralabel use of (b)(4) resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c).
 
In addition, our investigation found that you administer Furosemide Injection 5% to your lactating dairy cattle without following the dose as stated in the approved labeling or veterinarian prescription. Your extralabel use of Furosemide Injection 5% 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 administer (b)(4) to your heifer calves without following the duration and route of administration as stated in the approved labeling or veterinarian prescription. 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 administer (b)(4) to your heifer calves without following the duration and route of administration as stated in the approved labeling. (b)(4) is prohibited for extralabel use in cattle by 21 C.F.R. 530.41(a)(13)(ii).
 
In addition, our investigation found that you administer (b)(4) to your lactating dairy cattle 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 administer penicillin G procaine to your lactating dairy cattle without following the dose and duration as stated in the approved labeling. Your extralabel use of penicillin G procaine 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 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 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 Scott M. Loughan, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, Massachusetts 02180. If you have any questions about this letter, please contact Compliance Officer Scott M. Loughan at (802) 868-4725 X 109 or email at Scott.Loughan@fda.hhs.gov.
 
Sincerely yours,
/S/
Amber G. Wardwell
Acting District Director
New England District