• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Graham Dairy 2/21/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
 
Telephone: (615) 366-7801
FAX:   (615) 366-7802 

 

February 21, 2013
 
WARNING LETTER NO. 2013-NOL-07
 
 
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Justin Graham, Co-Owner
Graham Dairy
24527 Highway 10
Kentwood, Louisiana 70444
 
Dear Mr. Graham:
 
On October 16 – 19, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm, located at 24527 Highway 10, Kentwood, Louisiana. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) found during our investigation of your operation. You may find the Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov
 
We found you offered for sale an animal for slaughter as food that was adulterated. Under Section 402(a)(2)(C)(ii) of the Act, [21 United States Code (USC) 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 Act, [21 USC 360b]. Further, under Section 402(a)(4) of the Act, 21 USC 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 August 14, 2012, you sold a cow identified with back tag (b)(4), for slaughter as food. On or about August 16, 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 1.90 parts per million (ppm) of penicillin in the kidney tissue and 5.449 ppm of tilmicosin in the liver tissue. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (21 CFR), Part 556.510 and 1.2 ppm for residues of tilmicosin in liver tissue (target tissue) of cattle as codified in 21 CFR 556.735. However, FDA has not established a tolerance for the use of Micotil 300

Tilmicosin Injection (Tilmicosin, 300mg, NADA #140-929) in the edible tissue of female dairy cattle 20 months of age or older, as codified in 21 CFR 522.2471. 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 Act, [21 USC 342(a)(2)(C)(ii)].

Our investigation found you held animals under conditions that were so inadequate that medicated animals bearing potentially harmful drug residues were likely to enter the food supply. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. 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 Act, [21 USC 342(a)(4)].
 
We also found that you adulterated new animal drugs (b)(4)(Penicillin G Procaine, NADA #065-010), (b)(4)(Tilmicosin, 300mg, NADA #140-929), and (b)(4)(Penicillin G Procaine/Dihydrostreptomycin Sulfate, NADA #055-028). Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs in this manner is an extralabel use, as describe in 21 CFR 530.3(a). 
 
The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with Section 512(a)(4) and (5) of the Act, [21 USC 360b(a)(4) and (5)], and 21 CFR 530, and the use must be by or under the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. 
 
Our investigation found you administered (b)(4)(Penicillin G Procaine, NADA #065-010), to a dairy cow without following the dose and amount per injection site as stated in the approved labeling. Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian and in violation of 21 CFR 530.11(a). Your extralabel use of (b)(4) resulted in an illegal drug residue and in violation of 21 CFR 530.11(d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 CFR 530, you caused the drug to be unsafe under Section 512(a) of the Act, [21 USC 360b(a)], and adulterated within the meaning of Section 501(a)(5) of the Act, [21 USC 351(a)(5)].
 
Our investigation also found you administered Micotil 300 Tilmicosin Injection (Tilmicosin, 300mg, NADA #140-929), to a dairy cow without following the animal class and withdrawal period set forth in the approved labeling. Your extralabel use of Micotil 300 Tilmicosin Injection was not under the supervision of a licensed veterinarian and in violation of 21 CFR 530.11(a) and your extralabel use of Micotil 300 Tilmicosin Injection resulted in an illegal drug residue and in violation of 21 CFR 530.11(c). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 CFR 530, you caused the drug to be unsafe under Section 512(a) of the Act, [21 USC 360b(a)], and adulterated within the meaning of Section 501(a)(5) of the Act, [21 USC 351(a)(5)].
 
Our investigation found that you administered (b)(4)(Penicillin G Procaine / Dihydrostreptomycin Sulfate, NADA #055-028) to your dairy cows without following the meat withdrawal period as stated in the approved labeling. Your extralabel use of this drug was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 CFR 530, you caused the drugs to be unsafe under Section 512(a) of the Act, [21 USC 360b(a)], and adulterated within the meaning of Section 501(a)(5) of the Act, [21 USC 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 are 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 which may assist us in evaluating your corrections.
 
Please send your written reply to this letter to the U.S. Food and Drug Administration, Attention:  Kimberly A. Dutzek, Compliance Officer, 404 BNA Drive, Building 200, Suite 500, Nashville, Tennessee 37217. If you have any questions regarding this letter, please contact Compliance Officer Kimberly A. Dutzek at (615) 366-7826.
 
Sincerely yours,
/S/
Patricia K. Schafer
District Director


 

cc:        Brent Robbins, DVM
            State Veterinarian
            LA Department of Agriculture & Forestry
            5825 Florida Boulevard
            Baton Rouge, Louisiana 70821
 
            Diane Stacy, DVM
            Assistant State Veterinarian
            LA Department of Agriculture & Forestry
            5825 Florida Boulevard         
            Baton Rouge, Louisiana 70821
 
            Robert Babin
            Director of Meat and Poultry Inspections
            LA Department of Agriculture & Forestry
            5825 Florida Boulevard
            Baton Rouge, Louisiana 70821
 
            Thomas L. Hulsey, DVM
            Amite Animal Clinic
            60068 Thomas Road
            Amite, Louisiana 70422
 
            Lane Graham, Co-Owner
            Graham Dairy
            24527 Highway 10
            Kentwood, Louisiana 70444
 
            Scott E. Seebohm, DVM, Deputy Director
            United States Department of Agriculture
            Food Safety and Inspection Service
            Office of Policy and Program Development
            Policy Development Division
            1616 Capitol Ave, Suite 260
            Omaha, NE 68102