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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Gallagher Farms, LLC 5/5/14

  

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 

May 5, 2014
 

WARNING LETTER NYK 2014-31

VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED

Erik R. Gallagher, Co-Owner
Edward Gallagher, Co-Owner
Gallagher Farms, LLC
2341 State Route 315
Deansboro, New York 13328-1425
 

Dear Messrs. Gallagher:

On February 18, 25 and 26, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm located at 2314 State Route 315, Deansboro, 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 inspection 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 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 May 28, 2013, you sold a dairy cow, identified with farm tag (b)(4) and NYS metal tag (b)(4), and subsequently with sale tag (b)(4) for slaughter as food. On or about May 30, 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 tilmicosin at 1.967 parts per million (ppm) in the liver. FDA has established a tolerance of 1.2 ppm for residues of tilmicosin in the liver tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.735 (21 C.F.R. 556.735). However, this tolerance does not apply to the use of (b)(4) (tilmicosin injection) NADA (b)(4), in female dairy cattle 20 months of age or older, and there is no acceptable level of residue associated with the use of this drug in female dairy cattle 20 months of age or older. The presence of this drug in edible tissue from this animal in this amount 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)(tilmicosin phosphate injection) (NADA (b)(4)), (b)(4) (penicillin G procaine Injectable Suspension) (NADA (b)(4)), and (b)(4)(oxytetracycline) (ANADA (b)(4)). Specifically, our investigation revealed you did not use these drugs as directed by their approved labeling. Use of these drugs in this manner is an extralabel use as defined under 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 dairy cow identified with farm tag (b)(4) without following the animal class and the withdrawal period as stated 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), and your extralabel use resulted in an illegal residue, in violation of 21 C.F.R. 530.11(c).

Our investigation also found that you administered (b)(4) to your dairy cows (b)(4) and (b)(4) without following the dose, amount injected per site, and indications for use as stated 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).

In addition, our investigation found that you administer (b)(4) to your dairy cows without following the dose, amount injected per site, and indications for use as stated 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).

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).

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 Patricia A, Clark, 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 Patricia A, Clark by phone at (716) 846-6236 or email at patricia.clark@fda.hhs.gov.
 

Sincerely,
/S/
Ronald M. Pace
District Director
New York District