| Public Health Service Food and Drug Administration |
| Dallas District 4040 North Central Expressway Dallas, Texas 75204-3128 |
Department of Health and Human ServicesWARNING LETTER
September 24, 2010
2010-DAL-WL-16
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Harry Van Kranenburg, Owner
Kranenburg Dairy
16495 N FM 219
Dublin, Texas 7644
Dear Mr. Kranenburg:
On July 20, 2010 through July 22, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 16495 N FM 219, Dublin, Texas. 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 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 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 February 26, 2010, you sold a Holstein dairy cow identified with Green Ear Flap Tag number (b)(4) Back Tag number (b)(4), for slaughter as food to (b)(4). On February 26, 2010, (b)(4) slaughtered this animal. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue 'samples collected from this animal (FSIS sample number 527029) identified a residue of Ceftiofur, in the form of the marker residue desfuroylceftiofur, at a level of 44.01 ppm in the kidney.
The FDA has established a tolerance of 0.4 ppm for the marker residue desfuroylceftiofur in the kidney tissues of cattle, as codified in Title 21, Code of Federal Regulations (C.F.R.), 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. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time. For example, you failed to maintain complete treatment records for your dairy cows that you medicate in that your records lack the dosage given, the route of administration, identity of the individual administering the drug, and the required withdrawal time for the drug given. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the 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.
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 Ronda Loyd-Jones, Compliance Officer, U.S. Food and Drug Administration, at the above letterhead address. If you have any questions about this letter, please contact Ronda Loyd-Jones at 214-2535242 or Shari Shambaugh, Director Compliance Branch at 214-253-5215.
Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
Dallas District Director
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