Inspections, Compliance, Enforcement, and Criminal Investigations
Jernigan Dairy 3/26/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
DELIVERY SIGNATURE REQUESTED
March 26, 2014
Margaret F. Jernigan, Owner
1450 McLean Road
Fallon, Nevada 89406-5858
Dear Mrs. Jernigan:
On February 3, 4, and 6, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1450 McLean Road, Fallon, Nevada. 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 September 11, 2013, you sold a cow (ear tagged (b)(4), for slaughter as food to (b)(4). On September 12, 2013, (b)(4) slaughtered this cow. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this cow identified the presence of penicillin at 0.341 parts per million (ppm) in the kidney tissue. We also found that on or about October 2, 2013, you sold a cow (ear tagged (b)(4), for slaughter as food to (b)(4). On October 3, 2013, (b)(4) slaughtered this cow. USDA/FSIS analysis of tissue samples collected from this cow identified the presence of penicillin at 0.151 ppm in the kidney 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 (C.F.R.), Section 556.510 (21 C.F.R. 556.510). The presence of this drug in edible tissue from these animals in these amounts cause 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 penicillin G procaine injectable suspension ((b)(4) brand (b)(4), NADA (b)(4), and flunixin meglumine injectable solution (b)(4) brand (b)(4), ANADA (b)(4). Specifically, our investigation revealed that you did not use penicillin G Procaine and flunixin as directed by their approved labeling and/or your servicing veterinarian’s prescription. Use of these drugs in this manner is an extralabel use. See 21 C.F.R. 530.3(a). We have enclosed a copy for your reference.
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 penicillin G procaine injectable suspension (b)(4) brand (b)(4), NADA (b)(4) to two of your dairy cows identified with ear tags (b)(4) and (b)(4) without following the dosage and conditions for use as stated in the approved labeling. Your extralabel use of penicillin G procaine was not under the supervision of a licensed veterinary in violation of 21 C.F.R. 530.11(a) and your extralabel used resulted in illegal drug residues, in violation of 21 C.F.R. 530.11(d).
Our investigation also found that you administered flunixin meglumine injectable solution (b)(4) brand (b)(4), ANADA (b)(4) to your dairy cows without following the route of administration as stated in your servicing veterinarian’s prescription. Your extralabel use of flunixin meglumine injectable solution 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, 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 Lawton W. Lum, Director, Compliance Branch, U.S. Food and Drug Administration, San Francisco District, at 1431 Harbor Bay Parkway, Alameda, California 94502. If you have any questions about this letter, please contact Compliance Officer Karen L. Robles at (916) 930-3674 extension 1114 or via e-mail at Karen.Robles@fda.hhs.gov.
Kathleen M. Lewis, J.D.
San Francisco District
U. S. Food and Drug Administration