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  5. Newell Farms - 06/09/2014
  1. Warning Letters

WARNING LETTER

Newell Farms

Product:
Animal & Veterinary

Recipient:
Newell Farms


United States

Issuing Office:
Detroit District Office

United States


   

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

Public Health Service
Food and Drug Administration
  Detroit District
300 River Place
Suire 5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393·8139 

 

WARNING LETTER
 2014-DET-10
 
June 9, 2014
 
VIA UPS
 
Kenneth E. Newell, Owner
Newell Farms
14757 West Briggs Road
Trufant, Michigan 49347
 
 
 
Dear Mr. Newell:
 
On May 6, 8, and 14, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 2054 Amble Road, Coral, Michigan. 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 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 October 21, 2013, you sold a cow, identified with back tag (b)(4) (ear tag # (b)(4)) for slaughter as food. On or about October 22, 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 6.28 parts per million (ppm) of desfuroylceftiofur (marker residue for ceftiofur) in the kidney and 0.879 ppm of flunixin in the liver. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113(b)(3)(i) (21C.F.R. 556.113(b)(3)(i)). FDA has established a tolerance of 0.125 ppm for residues of flunixin in the liver tissue of cattle as codified in 21, C.F.R. 556.286(b)(1)(i). 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 and you held expired drugs in your drug inventory. 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 Naxcel (ceftiofur sterile powder, NADA 140-338) and Prevail (flunixin meglumine injectable solution ANADA 200-387). Specifically, our investigation revealed that you did not use Naxcel and Prevail as directed by their approved labeling and/or your servicing veterinarian’s 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 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 Naxcel and Prevail to a dairy cow with back tag (b)(4) (ear tag # (b)(4)) without following the specified withdrawal period as stated in the approved labeling or your servicing veterinarian’s prescription. Your extralabel use of Naxcel and Prevail were not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of Naxcel and Prevail 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 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 receipt of your May 15, 2014 letter responding to the violative levels of drug residues found in your cow with back tag (b)(4) (ear tag (b)(4)) and our inspectional findings related to this violation reported to you in our Inspectional Observations Form FDA 483 issued on May 14, 2014. We can only determine the effectiveness of your corrective actions over time.
 
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 Tina M. Pawlowski, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions about this letter, please contact Compliance Officer Pawlowski at (313) 393-8217 or by email at tina.pawlowski@fda.hhs.gov. 
 
Sincerely,
/S/ 
Art O. Czabanuik
Acting District Director
Detroit District Office
 
 
Cc:       Melanie A. Hart
            Cervid and Reportable Disease Program Secretary
            Michigan Department of Agriculture and Rural Development
            Animal Industry Division