• 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

Falls View Farm 2/20/14

  

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 

 

February 20, 2014
 
WARNING LETTER NYK-2014-20 
 
 
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Mr. Matthew A. Surawski, Owner
Falls View Farm
643 Hayner Road
Richfield Springs, New York 13439-3712
 
Dear Mr. Surawski:
 
On October 2, 24, and November 15, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 643 Hayner Road, Richfield, New York 13439-3712. 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 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 two animals for slaughter as food that were 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 5, 2013, you sold a bob veal calf, identified with back tag (b)(4) and ear tag # (b)(4), for slaughter as food. On or about June 6, 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 9.02 parts per million (ppm) of Neomycin residue in the kidney. In addition, our investigation revealed that on or about March 11, 2013, you sold a bob veal calf, identified with ear tag # (b)(4)  and MCT/Sales Tag # (b)(4), for slaughter as food. On or about March 13, 2013, (b)(4), slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of 14.91 parts per million (ppm) of Neomycin residue in the kidney. FDA has established a tolerance of 7.2 ppm for residues of Neomycin in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.430 (21 C.F.R. 556.430). However, this tolerance does not apply to the use of (b)(4) containing Neomycin Sulfate (10.0 grams/lb.) and Oxytetracycline Hydrochloride (10.0 grams/lb.) in bob veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with the use of the drug (Neomycin) in bob veal calves (pre-ruminating calves). The presence of Neomycin 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 treatment records for the calves treated. Furthermore, your firm does not have a system in place to control the administration of drug treatments to animals as evidenced by your employees feeding the (b)(4) to two bull calves resulting in the above Neomycin residues. 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 Neomycin Sulfate and Oxytetracycline Hydrochloride found in (b)(4) containing Neomycin Sulfate (10.0 grams/lb.) and Oxytetracycline Hydrochloride (10.0 grams/lb.). Specifically, our investigation revealed that you did not use the medicated supplement as directed by the product labeling. Use of (b)(4) 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 your employees fed (b)(4) containing Neomycin Sulfate (10.0 grams/lb.), to a class of animals (veal calf with back tag # (b)(4) and ear tag # (b)(4) and veal calf with ear tag # (b)(4) and MCT/Sales Tag # (b)(4)) not set forth in the approved labeling in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use of (b)(4) resulted in illegal residues, in violation of 21 C.F.R. 530.11(c). Because your use of this medicated supplement was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug in the medicated supplement 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).
 
In addition, you adulterated (b)(4) containing Neomycin Sulfate (10.0 grams/lb.) within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. 351(a)(6), when you failed to use this medicated supplement in conformance with its approved labeling. Your use of this medicated supplement without following the animal class as directed by the approved labeling caused this medicated supplement to be unsafe within the meaning of section 512 of the FD&C Act, 21 U.S.C. 360b. Section 512 of the FD&C Act, 21 U.S.C. 360b, and 21 C.F.R. 530.11(b) do not permit the extra-label use of medicated feed.
 
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. 
 
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, 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 Lillian C. Aveta at (718) 662-5576 or Email at Lillian.Aveta@fda.hhs.gov.
 
 
Sincerely yours,
/S/
Ronald M. Pace
District Director
New York District