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WARNING LETTER

Cowles Farms, LLC MARCS-CMS 448882 —

Product:
Animal & Veterinary

Recipient:
Recipient Name
Mr. Thurlow Y. Cowles
Cowles Farms, LLC

1818 Oak Hill Rd.

Marietta, NY 13110-9738
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 

 

January 30, 2015
 
WARNING LETTER NYK-2015-22  
 
 
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Mr. Thurlow Y. Cowles, Co-Owner
Mr. Jonathan Cowles, Co-Owner
Cowles Farms, LLC
1818 Oak Hill Rd.
Marietta, New York 13110-9738
 
 
Dear Messers Cowles:
 
On December 5 and 11, 2014, the Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 1818 Oak Hill Road, Marietta, New York. This letter notifies you of 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 June 10, 2014, you sold a bob veal calf identified with back tag (b)(4) for slaughter as food.  On or about June 12, 2014, (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 (marker residue for ceftiofur) at 1.48 parts per million (ppm) in the kidney and the presence of flunixin in the kidney. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in 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)). Additionally, in accordance with 21 C.F. R. 522.970, flunixin is not permitted for use in calves to be processed for veal. Therefore, the presence of these drugs in edible tissues 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). Specifically, our investigation revealed that you did not use (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 bob veal calf with ear tag (b)(4) without following the dosage as stated in the approved label. Also, our investigation found that you administered (b)(4) to a class of animal, veal calves, not set forth in the approved labeling. Our investigation also found that you administered (b)(4) to a bob veal calf with ear tag (b)(4), a class of animal not set forth 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). Your extralabel use of ( b4 ) resulted in an illegal drug residue, in violation of 21 C.F.R. § 530.11(d). Your extralabel use of (b)(4) resulted in an illegal drug residue, in violation of 21 C.F.R. § 530.11(c). Your extralabel use of a cephalosporin (b)(4) at an unapproved dosage, is prohibited by 21 C.F.R. § 530.41(13)(ii). 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 these drugs to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360(b)(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 lasalocid) 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 the medicated feed in conformance with its approved labeling. Your use of this medicated feed without following the animal class as directed by the approved labeling caused this medicated feed to be unsafe under 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 extralabel use of medicated feeds.
 
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 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 timeframe 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 Catherine M. Beer, Compliance Officer, U.S. Food and Drug Administration, 1 Winners Circle, Suite 110, Albany, New York 12205. If you have any questions about this letter, please contact Compliance Officer LCDR Catherine M. Beer at (518) 453-2314 x1015, or by e-mail at Catherine.beer@fda.hhs.gov.
 
 
Sincerely,
/S/
Ronald M. Pace
District Director
New York District