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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Brockway Hilltop Farms LLC 7/25/13

  

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 

 

July 25, 2013
 
WARNING LETTER NYK-2013-25
 
 
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Kevin E. Brockway, Partner
Brockway Hilltop Farms LLC
50 County Route 43
Fort Covington, New York 12937-2901
 
Dear Mr. Brockway:
 
On March 7, 11, and April 10, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 50 County Route 43, Fort Covington, New York 12937-2901. 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 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 September 27, 2012, you sold a bob veal calf, identified with ear tag (b)(4) for slaughter as food. On or about September 28, 2012, (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 metabolite of ceftiofur, at 3.25 parts per million (ppm) in the kidney tissue and the presence of Dexamethasone 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. FDA has not established a tolerance for residues of Dexamethasone in the edible tissues of cattle. 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).
 
In addition, our investigation revealed that on or about October 03, 2012, you sold a bob veal calf, identified with ear tag (b)(4) for slaughter as food. On or about October 04, 2012, (b)(4), slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of desfuroylceftiofur, a metabolite of ceftiofur, at 1.21 ppm in the kidney tissue and the presence of Dexamethasone 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 21 C.F.R. 556.113. FDA has not established a tolerance for residues of Dexamethasone in the edible tissues of cattle. 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 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)(ceftiofur sodium, (b)(4)) and Dexamethasone Solution ((b)(4)). Specifically, our investigation revealed that you did not use (b)(4) and Dexamethasone as directed by their approved labeling or by the 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 (b)(4)(ceftiofur sodium (b)(4)) and Dexamethasone Solution ((b)(4)) to your bob veal calves identified with ear tags (b)(4) and (b)(4) without following the prescribed or approved labeling. Your extralabel use of (b)(4) and Dexamethasone Solution was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Your extralabel use of (b)(4) resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d) and your extralabel use of Dexamethasone Solution resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). 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. 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. An undated letter was received by the district on April 16, 2013. The hand written letter states your firm has addressed the observations made during the recent inspection conducted on March 07 to April 10, 2013, to prevent future violations. Although your letter indicates that you have taken steps to address our observations, you do not mention what steps were taken or what preventive measures, if any, are in place. Based on your firm's history of residues, 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 Dean R. Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 622 Main Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Dean R. Rugnetta at (716) 846-6207 or email at Dean.Rugnetta@fda.hhs.gov.
 
Sincerely yours,
/S/ 
Ronald M. Pace
District Director
New York District