Inspections, Compliance, Enforcement, and Criminal Investigations
Wright Family Dairy 10/28/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Atlanta District Office
VIA UNITED PARCEL SERVICE
William P. Wright, Jr., President
Wright Family Dairy
18 Holstein Lane
Baxley, Georgia 31513
Dear Mr. Wright:
On June 29, 2010 and July 1, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 18 Holstein Lane, Baxley, Georgia. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that we found during our investigation of your operation. You can find the 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 the dates of January 25, 2010 and February 15, 2010, you sold a dairy cow each day identified with ear tag numbers (b)(4) respectively, for slaughter as food. On or about January 26, 2010 and February 16, 2010, (b)(4) slaughtered these animals. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from the first animal identified the presence of 0.151 parts per million (ppm) of flunixin in the liver tissue. USDA/FSIS analysis of tissue samples collected from the second animal identified the presence of 0.512 parts per million (ppm) of flunixin in the liver tissue. FDA has established a tolerance of 0.125 ppm for residues of flunixin in the liver of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.286 (21 C.F.R. 556.286). The presence of flunixin in the 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 maintain complete treatment records. Your records failed to include the amount of drug administered, route of administration, and the withdrawal time required prior to slaughter. 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 drug, flunixin meglumine. Specifically, our investigation revealed that you did not use flunixin meglumine as directed by your veterinarian's prescription labeling. Use of this drug in this manner is an extralabel use. 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. 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 flunixin meglumine to a dairy cow without following the withdrawal times as stated in the approved labeling and as stated in your veterinarian's prescription labeling. Also, our investigation found that you administered flunixin meglumine to two (2) dairy cows without following the dose as stated in your veterinarian's prescribed labeling. Your extralabel use was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of flunixin meglumine resulted in illegal drug residues, in violation of 21 C.F.R. 530.11(d). Because your use of this drug was not in conformance with its approved labeling, nor your veterinarian's prescribed labeling, and did not comply with 21 C.F.R. 530, you caused the drug 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 above violations 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. A letter dated July 1, 2010, was received addressing the observations made during the inspections we conducted at your location in Baxley, Georgia. Although your letter indicates that your firm has taken steps to address our observations, your response did not contain enough detail for us to evaluate as to their adequacy. The corrections your firm has implemented will be evaluated and verified during our next inspection.
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, 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 Philip S. Campbell, Compliance Officer, U.S. Food and Drug Administration, 60 8th Street, N.E., Atlanta, Georgia 30309. If you have any questions about this letter, please contact Compliance Officer Campbell at (404) 253-1280.
John R. Gridley