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  1. Warning Letters

WARNING LETTER

McCormick Family Dairy, LLC

Product:
Animal & Veterinary

Recipient:
McCormick Family Dairy, LLC


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
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433 
December 7, 2015
 
WARNING LETTER NYK-2016-14
 
 
VIA UNITED POSTAL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Mr. Daniel M. McCormick, Part Owner
Ms. Jennifer M. Reichart, Part Owner
Ms. Michelle N. Pohl, Part Owner
McCormick Family Dairy, LLC
10889 Sandpit Road
Alexander, New York 14005
 
Dear Mr. McCormick, Ms. Reichart and Ms. Pohl:
 
On August 21, August 24, August 25, August 31 and September 30, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 10889 Sandpit Road, Alexander, 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 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 March 9, 2015, you sold a veal calf identified with (b)(4) for slaughter as food. On or about March 10, 2015, (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 ampicillin at 0.11 parts per million (ppm) in the kidney and 0.06 ppm in the muscle. Our investigation also revealed that on or about July 27, 2015, you sold a veal calf, identified with (b)(4), for slaughter as food. On or about July 28, 2015, (b)(4), slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of sulfamethazine at 2.27 ppm in the muscle and 6.19 ppm in the liver. FDA has established a tolerance of 0.01 ppm for residues of ampicillin in uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.40 (21 C.F.R. 556.40). Also, FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in uncooked edible tissues of cattle as codified in 21 C.F.R. 556.670. The presence of these drugs in edible tissues from these animals 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 have a system to control administration of drug treatments to your animals and 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 Polyflex (ampicillin, NADA 055-030) and Aureo S-700 3.5G Crumbles (chlortetracycline HCL and sulfamethazine). Specifically, our investigation revealed that you did not use Polyflex and Aureo S-700 3.5G Crumbles 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 Polyflex to a calf identified with (b)(4) without following the dosage instructions and without following the indications for use as set forth in the approved product labeling or veterinary prescription. Your extralabel use of Polyflex was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of Polyflex resulted in an illegal residue, in violation of 21 C.F.R. 530.11(d). Our investigation also found that you administered Aureo S-700 3.5G Crumbles to a calf identified with (b)(4) without following the animal class as stated in the approved labeling.  Your extralabel use of Aureo S-700 3.5G Crumbles was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of Aureo S-700 3.5G Crumbles resulted in an illegal residue, in violation of 21 C.F.R. 530.11(d). 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 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).
 
In addition, you adulterated the medicated feed Aureo S-700 3.5G Crumbles 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 within the meaning of section 512 of the Act, 21 U.S.C. 360b. Section 512 of the Act, 21 U.S.C. 360b, and 21 C.F.R. 530.11(b) do not permit the extralabel 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. 
 
Our investigation also revealed that on January 15, 2014, you submitted a Drug Free Residue Affidavit and Livestock Owner’s Certificate to (b)(4) that states that the animals presented for slaughter do not have an illegal level of drug residues. On March 9, 2015, you delivered a veal calf, which contained violative residues of ampicillin, from your farm to (b)(4). Our investigation also revealed that, on July 27, 2015, you delivered a veal calf which contained violative residues of sulfamethazine from your farm to (b)(4). Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. § 331(h). You should take appropriate actions to ensure that this violation does not recur.
 
We have received your firm’s response, dated September 30, 2015, regarding the inspection of your farm. It has been made a part of the permanent file of your farm and will be considered with other records there. We will assess the impact of your proposed corrective actions in a future inspection or via another assessment mechanism.
 
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 CDR Frank Verni, 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 Frank Verni at (718) 662-5702 or by e-mail at frank.verni@fda.hhs.gov.
 
Sincerely,
/s/
Ronald Pace
District Director
New York District
 
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