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  5. R and D Adams - 04/23/2015
  1. Warning Letters

WARNING LETTER

R and D Adams

Product:
Animal & Veterinary

Recipient:
R and D Adams


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, New York 11433 

April 23, 2015
 

WARNING LETTER NYK 2015-31

VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED

Mr. David A. Adams, Co-Owner
Rand D Adams
d/b/a/ David and Lisa Adams Dairy Farm
4284 Elm Creek Road
Randolph, New York 14772-9430
 

Dear Mr. Adams:
 

On January 21, 27, and February 11, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 4284 Elm Creek Road, Randolph, New York 14772-9430. 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 June 9, 2014, you sold a dairy cow, identified with back tag (b)(4), for slaughter as food. On or about June 10, 2014, (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 0.195 parts per million (ppm) of flunixin residue in the liver. FDA has established a tolerance of 0.125 ppm for residues of flunixin in the liver (target tissue) of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.286 (21 C.F.R. 556.286). The presence of this drug in edible tissues from these animals in the amounts stated 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 did not record the use of flunixin when you treated your dairy cows. 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 drug, (b)(4), (Flunixin Meglumine, NADA #(b)(4)). Specifically, our investigation revealed that you did not use (b)(4) as directed by the 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) (Flunixin Meglumine, NADA #(b)(4)) to a dairy cow with back tag (b)(4) without following the route of administration and the slaughter withdrawal time set forth in the approved product 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 illegal residues, in violation of 21 C.F.R. 530.11(d). 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 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.

We acknowledge a response was received from you dated February 23,2015. However, this response is not adequate for the following reason: Your response does not describe the actual corrective actions you have taken or plan to take to prevent further illegal drug residues.

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 tifteen (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 Patricia A. Clark, Compliance Officer, U.S. Food and Drug Administration, 622 Main Street, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Patricia A. Clark at (716) 846-6236 or E-mail at patricia.clark@lfda.hhs.gov.
  

Sincerely yours,
/S/
Ronald M. Pace
District Director
New York District 

 

cc: Mr. Ronald Adams, Co-Owner
R and D Adams
d/b/a/ David and Lisa Adams Dairy Farm
4284 Elm Creek Road
Randolph, New York 14772-9430