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  5. Phillip Thompson - 08/10/2016
  1. Compliance Actions and Activities

WARNING LETTER

Phillip Thompson

Product:
Animal & Veterinary

Recipient:
Phillip Thompson


United States

Issuing Office:
Baltimore District Office

United States


   

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

Public Health Service
Food and Drug Administration
  Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5705 

 

WARNING LETTER
CMS#499493
 
August 10, 2016
 
Mr. Phillip D. Thompson
1183 3 Beaver Dam Road
Union Bridge, Maryland 21791-8627
 
Dear Mr. Thompson,
 
On May 2 and 11, 2016, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dairy operation located at 11833 Beaver Dam Road, Union Bridge, Maryland. This letter notifies you of the violations of the Federal Food, Drug and Cosmetic Act (the FD&C Act) that we found during our inspection of your operation. You can find the FD&C Act and associated regulations on the Internet through links on the 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 September 17, 2015 you sold a dairy cow identified with ear tag number (b)(4) for slaughter as food. On or about September 18, 20 15, (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 ceftiofur at 2.95 parts per million (ppm) in kidney tissue and flunixin at 0.162 ppm in liver tissue. The FDA has established a tolerance of 0.4ppm for residues of ceftiofur in kidney tissue and 0.125pm for residues of flunixin in the liver of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), section 556.113 (b)(3)(i) and 556.286 (b)(1)(i). The presence of these drugs in edible tissue from an animal in these amounts 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 maintained inadequate treatment records for animals that you medicate; you had no inventory system for determining the quantities of drugs used to medicate your animals; and you failed to maintain records regarding the identity of the animal(s) that you transport and deliver for consignment at an auction yard. 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 Excenel RTU EZ (ceftiofur hydrochloride, NADA 141-288) and Banamine® (flunixin meglumine, NADA 101-479). Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling or veterinary prescription. The use of these drugs in this manner is extralabel use. See 21 C.F.R. 530.3(a). We have enclosed a copy of this regulation for your reference.
 
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 Excenel RTU EZ and Banamine® to the dairy cow identified with ear tag number (b)(4) without following the withdrawal period as listed in the approved labeling or the veterinary prescription (four days, respectively). In addition, our investigation found that you administered Banamine to the dairy cow identified with ear tag number (b)(4) without following the route of administration as stated in the approved labeling. Specifically, you administered Banamine® in the muscle rather than in the vein as stated in the approved labeling. Your extralabel use of Excenel RTU EZ and Banamine® was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a), and your extralabel use of these drugs resulted in an illegal drug residue, 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 reoccur. 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 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 15 working days from 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 Ms. Evelyn Bonnin, District Director, Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, MD, 21215. If you have any questions regarding this letter, please contact CDR Rochelle B. Young, RPh, MSA, Compliance Officer, at 410-779-5437 or rochelle.young@fda.hhs.gov.
 
 
Sincerely,
/S/
Evelyn Bonnin
District Director
Baltimore District