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  5. Reuben R. Zimmerman - 11/12/2014
  1. Compliance Actions and Activities

WARNING LETTER

Reuben R. Zimmerman

Product:
Animal & Veterinary

Recipient:
Reuben R. Zimmerman


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, NY 11433 

 

November 12, 2014
 
WARNING LETTER NYK-2015-7
 
 
VIA UNITED POSTAL SERVICE
DELIVERY SIGNATURE REQUESTED
 
 
Mr. Rueben R. Zimmerman, Owner
2529 Himrod Road
Penn Yan, New York 14527
 
Dear Mr. Zimmerman:
 
On September 15 and 17, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 2529 Himrod Road, Penn Yan, 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 within the meaning of 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 Sale Tag #(b)(4) and New York State Metal Ear Tags #(b)(4) and #(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 0.631 parts per million (ppm) of penicillin in edible kidney tissue and the presence of 1.3 ppm flunixin in the liver and the presence of 0.0293 ppm flunixin in the muscle. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the uncooked edible tissues of cattle, as codified in 21 C.F.R. 556.510(a). FDA has established a tolerance of 0.125 ppm for residues of flunixin in the liver tissue of cattle and 0.025 ppm for residues of flunixin in the muscle tissue of cattle, as codified in 21 C.F.R. 556.286(b)(1)(i) and 21C.F.R. 556.286(b)(1)(ii) . The presence of these drugs in edible tissue from this 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 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) brand Penicillin Injectable (penicillin G procaine, NADA (b)(4)), and (b)(4) (ceftiofur hydrochloride NADA (b)(4)). Specifically, our investigation revealed that you did not use (b)(4) brand Penicillin Injectable 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 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) Brand Penicillin to a dairy cow, identified with Sale tag #(b)(4) and New York State Metal Tags #(b)(4) and #(b)(4), without following the withdrawal time and route of administration as stated in the approved label. Your extralabel use of penicillin was not under the supervision of a licensed veterinarian, in violation of 21 C. F. R. 530.11(a) and your extralabel use of penicillin resulted in an illegal drug residue in violation of 21 C.F.R. 530.11(d). 
 
Our investigation found that you administered (b)(4) (ceftiofur hydrochloride NADA (b)(4)) to a dairy cow identified with Sale tag #(b)(4) and New York State Metal Tags #(b)(4) and #(b)(4), 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). Certain uses of ceftiofur (e.g.at unapproved doses, frequencies, durations, or routes of administration) are prohibited for extralabel use in cattle by 21 C.F.R. 530.41(a)(13)(ii).
 
Because your use of these drugs was not in conformance with the approved labeling and did not comply with 21 C.F.R. 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).
 
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.
 
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 Compliance Officer Jackson at (718)662-5711 or kristen.jackson@fda.hhs.gov.
 
 
Sincerely yours,
/S/
Ronald M. Pace
District Director
New York District