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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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O'Dell Farms 8/8/14

  

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
(718) 340-7000 

 

August 8, 2014
 
WARNING LETTER  NYK-2014-56
 
 
 
VIA UNITED POSTAL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Jonathan  R. O'Dell, Co-Owner
William J. O'Dell, Co-Owner
O'Dell  Farms Partnership
422 Willetts Road
Panama, New York 14767-9705
 
 
Dear Messrs. Jonathan R. O'Dell and William J. O'Dell;
 
 
On May 28, June 5 and June 12, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 422 Willetts Road, Panama, 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 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 September  24, 2013, you sold a cow, identified  with back tag (b)(4) (ear tag # (b)(4)) for slaughter as food.  On or about September 25, 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 0.73 parts per million (ppm) of desfuroylceftiofur (marker residue for ceftiofur) in the kidney and 0.267 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) (21 C.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.  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) (flunixin meglumine, ANADA (b)(4)) and (b)(4) (ceftiofur hydrochloride, ANADA (b)(4)). Specifically, our investigation revealed that you did not use (b)(4) 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 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) to a cow with back tag (b)(4) (ear tag #(b)(4)) without following the specified route of administration or indication for use as stated in the approved label. Also, our investigation found that you administered (b)(4) to a cow with back tag (b)(4) (ear tag #(b)(4)) without following the indication for use as stated in the approved label.  Your extralabel use of (b)(4) and (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) and (b)(4) 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 the approved labeling and did not comply with 21 C.P.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 June 25, 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 June 12, 2014.  Since examples of your proposed new protocols and records were not provided, we have no basis to determine their effectiveness or significance. 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.
 
Please send your' reply to:  Patricia A. Clark,Compliance  Officer, U.S. Food and Drug Administration,  622 Main Street, Suite 100, Buffalo, New York 14202.  If you have questions regarding any issues in this letter, please contact Compliance Officer Clark at 716-846-6236 or by email at patricia.clark@fda.hhs.gov.
 
Sincerely yours,
/S/ 
Ronald M. Pace
District Director
New York District
 
 
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