North Star Dairy 1/16/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Dallas District|
4040 North Central Expressway
Dallas, Texas 75204-3128
January 16, 2013
William Jongsma, President
North Star Dairy, LLC.
295 US Highway 385
Hereford, TX 79045-7913
Dear Mr. Jongsma:
On September 10, 14, and 17, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 295 U.S. Hwy 385, Hereford, Texas. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that were 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 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 April 9, 2012, you sold a dairy cow identified with tag number (b)(4) for slaughter as food. On or about April 9, 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 cefazolin in the kidney. FDA has not established a tolerance for residues of cefazolin in the edible tissues of cows. The presence of this drug in edible tissue from this animal 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 and to segregate treated animals. 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 you adulterated the new animal drugs (b)(4) (ceftiofur hydrochloride), NADA (b)(4); (b)(4) (ceftiofur), NADA (b)(4); (b)(4) (ceftiofur sodium), NADA (b)(4); and (b)(4) (ceftiofur sodium), ANADA (b)(4). Specifically, our investigation revealed that you did not use these ceftiofur animal drugs as directed by their approved labeling. Use of these drugs in this manner is an extralabel use. See 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. 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 a ceftiofur drug to a dairy cow with tag number (b)(4) without following the withdrawal period as stated in the approved labeling. Your extralabel use of ceftiofur 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 and did not comply with 21 C.F.R. Part 530, you caused these 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 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.
Our investigation also revealed that on or about September 15, 2008, you provided (b)(4) with a signed Producer’s Wholesomeness Certificate stating that none of the livestock shipped to or delivered to (b)(4) will have an illegal level of drug residues. This signed producer’s certificate covered the cow identified with tag (b)(4), which was found to contain a violative cefazolin residue. Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. 331(h). You should take appropriate actions to ensure this violation does not recur.
We acknowledge your October 8, 2012, response to the Form FDA 483 observations and have determined the corrective actions you have implemented are not adequate. It is not apparent what training has been provided to ensure your staff has full and complete knowledge of all drugs used at your dairy, nor how future violations will be prevented. Additionally, the withdrawal time for (b)(4) indicated on the treatment record dated October 21, 2012 is incorrect.
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.
Reynaldo R. Rodriguez, Jr.
cc: Mr. Robert C. Miersma, Operations Manager
North Star Dairy, LLC.
295 US Highway 385
Hereford, TX 79045
FSIS District Office 40
Attn: Dr. Jennifer Beasley-McKean, DM
1100 Commerce Street, Room 516
Dallas, TX 75242-0598
Texas Department of State Health Services
1100 W. 49th Street
Austin, TX 78756