Public Health Service
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
June 5, 2014
Rod W. McNeal, Owner
Rod McNeal Dairy
405 PR 1375
Dublin, TX 76446
Dear Mr. McNeal:
On March 18 – 25, 2014 the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy located at 405 PR 1375, Dublin, Texas 76446. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the 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 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 October 7, 2013, you sold a cow, identified with ear tag (b)(4), for slaughter for food. On or about October 7, 2013, the cow with ear tag (b)(4) was slaughtered at (b)(4). The United States Department of Agriculture, Food Safety and Inspection Service’s (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 10.56 parts per million (ppm) of desfuroylceftiofur, the marker residue for ceftiofur, in the kidney. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in the kidney tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113 (21 C.F.R. 556.113). 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 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).
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.
We acknowledge the March 26, 2014 response to the Form FDA 483, Inspectional Observations, and have determined the corrective actions you have implemented are not adequate. Although your response states your firm has implemented a new record keeping system; you did not provide evidence to show the system has been implemented. Further, you did not identify the specific changes to the records you made to allow for a complete evaluation of the adequacy of your corrective actions at this time.
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 Jeff R. Wooley, Compliance Officer, U.S. Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, TX 75204. If you have any questions about this letter, please contact Compliance Officer Jeff R. Wooley at 214-253-5251.