Zeinstra Farms, LLC 4/26/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Detroit District|
300 River Place
Detroit, Ml 48207
April 26, 2013
Mr. Craig A. Zeinstra, Co-Owner
Mr. Ronald Zeinstra, Co-Owner
Mr. Todd Zeinstra, Co-Owner
Zeinstra Farms, LLC
913 122nd Avenue
Shelbyville, Michigan 49344-9730
Dear Messrs. Zeinstra:
On February 12, February 21, and March 8, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 913 122nd
Avenue, Shelbyville, Michigan. 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 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. 360(b). 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 October 30, 2012, you sold a dairy cow, identified with ear tag (b)(4) house tag (b)(4) for slaughter as food. On or about October 30, 2012, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of neomycin at 13.03 ppm and desfuroylceftiofur at 1.86 ppm in the kidney. FDA has established a tolerance of 7.2 parts per million (ppm) for residues of neomycin in the uncooked edible kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.430(b)(1) (21 C.F.R. 556.430(b)(1)). FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in kidney (target tissue) of cattle as codified in 21 C.F.R. 556.113(b)(3)(i). The presence of these drugs in edible tissue from this animal 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).
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.
Our investigation also revealed that on or about November 20, 2003, you provided to (b)(4), a signed certification that states that the livestock you sell do not have illegal levels of drug residues. According to the certificate, it remains in effect until the undersigned delivers written notice of revocation to (b)(4). On or about October 30, 2012, you delivered a dairy cow identified with ear tag (b)(4), which contained violative residues of neomycin and desfuroylceftiofur, to (b)(4). 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 that this violation does not recur.
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 LCDR Kelli Wilkinson, Compliance Officer, U.S. Food and Drug Administration at 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions about this letter, please contact LCDR Wilkinson at 313-393-8120.
Art O. Czabaniuk
Acting District Director
Detroit District Office