• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Johnson Farm LLC 11/25/13

  

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 25, 2013
 
WARNING LETTER NYK-2014-9 
 
 
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
 
Mr. Michael R. Johnson, Co-Owner
Johnson Farm LLC
4995 State Highway 80
New Berlin, New York 13411-3407
 
Dear Mr. Johnson:
 
On July 30 and August 5, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 4995 State Highway, New Berlin, New York 13411. 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 28, 2013, you sold a culled dairy cow, identified with farm tag (b)(4) for slaughter as food. On or about March 1, 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 desfuroylceftiofur, a marker residue for ceftiofur, at 7.55 parts per million (ppm) in the kidney tissue. FDA has established a tolerance of 0.4 ppm for residues of ceftiofur in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113, 21 C.F.R. 556.113. 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. 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) (Ceftiofur Crystalline Free Acid, NADA #(b)(4). Specifically, our investigation revealed that you did not  use (b)(4) as directed by the approved labeling or by the servicing veterinarian’s prescription. 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) (Ceftiofur Crystalline Free Acid, NADA # (b)(4) to your culled dairy cow identified with farm tag # (b)(4)  without following the withdrawal period as stated on 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(d). Because your use of this drug was not in conformance with the approved labeling and did not comply with 21 C.F.R. Part 530, you caused this 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.
 
FDA acknowledges the written response we received following our inspection. A facsimile of a hand written letter was received by the district on August 14, 2013. The letter states your firm has implemented an additional treatment record and you provided a copy of said document with your response. However, your new record keeping system does not address the dosage and route of administration for the drug treatments. Also, your response fails to address how you intend to prevent further illegal tissue residue violations from occurring. Therefore, the effectiveness of your corrective measures can only be determined 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: Lillian C. Aveta, Compliance Officer, New York District Office, Food and Drug Administration, 158-15 Liberty Ave., Jamaica, New York 11433.   If you have any questions about the content of this letter please contact Ms. Aveta at 718-662-5576 or E-mail at lillian.aveta@fda.hhs.gov.
 
                                                                                   
Sincerely,
/S/ 
Ronald M. Pace
District Director
New York District
 
 
cc:       
Mr. Patrick G. Johnson, Co-Owner
Johnson Farm LLC
4995 State Highway 80
New Berlin, New York 13411
 
cc:      
(b)(4)
Johnson Farm, LLC.
4995 State Highway 80
New Berlin, NY 13411
 
cc:       
Dr. David Smith, Director (redacted copy)
Division of Animal Industry
New York State Department of Agriculture & Markets
10 B Airline Drive
Albany, New York 12235