Public Health Service Food and Drug Administration
Detroit District 300 River Place Suite 5900 Detroit, Ml 48207 Telephone: 313-393-8100 FAX: 313-393-8139
December 31, 2014
Danon C. Reeder, Owner
3473 Sunfield Highway
Ionia, Michigan 48846
Dear Mr. Reeder:
On October 7 through October 23, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 3098 Sunfield Hwy., Ionia, Michigan. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 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 March 6, 2014 you sold a dairy cow with back tag (b)(4), ear tag (b)(4), and retain tag (b)(4) for slaughter as food. On or about March 7, 2014, (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 desfuroylceftiofur at a level of 4.05 ppm in the kidney. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113(b)(3) (21 C.F.R. 556.113(b)(3)). The presence of these drugs in the edible tissues from this animal in these amounts causes the food to be adulterated under 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.
We acknowledge receipt of your written response, dated October 24, 2014, regarding the Form FDA 483 Inspectional Observations issued to you at the close of the above inspection. Your response states that you have accepted the responsibility for selling cow #(b)(4) for human consumption with an antibiotic residue over the limits. Your response also states that your treatment records now include: (b)(4). Also, each cow will (b)(4). We acknowledge the example blank (b)(4) record and new (b)(4); however, it appears even with previously limited documented treatment records an animal was not documented as treated and an animal was released within the withdrawal time.
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 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.