Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
300 River Place
Detroit, Ml 48207
December 16, 2014
Mr. Roger L. Masselink, Owner
Masselink Dairy Farm, LLC
10718 Green Lake Road
Middleville, Michigan 49333
Dear Mr. Masselink:
On October 28, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 10718 Green Lake Rd. Middleville, 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. 360b. 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 6/12/2014, you sold a dairy cow, identified with back tag # (b)(4) and ear tag # (b)(4) for slaughter as food through (b)(4). On or about 6/13/2014, (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 on 6/13/2014, identified the presence of desfuroylceftiofur, a marker residue for ceftiofur, at 8.42 parts per million (ppm) in the kidney tissue. FDA has established a tolerance of 0.4 ppm for residues of ceftiofur in the kidney tissue 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 tissues from this animal in this amount 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 we found that your treatment records do not include the dosages for each drug used, the route of administration for each drug, the name and initials of the person administering each drug, and the date the withdrawal period ends. Your treatment records documented that you treated dairy cow, identified with back tag # (b)(4) and ear tag # (b)(4), with Excenel (ceftiofur) on 6/10/2014, and this drug has a prescription call for a 4 day meat withhold. On 6/12/2014, two days after treatment, cow # (b)(4) was auctioned at (b)(4) and on 6/13/2014, tissue collected from cow # (b)(4) was found to have desufurolyceftiofur residues in kidney tissue above the FDA established tolerance. 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 received December 03, 2014 regarding the Form FDA 483 Inspectional Observations issued to you at the close of the above inspection. Your response states that you have changed the way you record treatments including: now reinstating you handwritten treatment records in addition to the incomplete computer record; and review all treatment records prior to selling a cow. Additionally, you state that you are now looking at all drug labels for proper treatment regime, which includes dose, frequency, duration, and route of administration. We acknowledge the example medication record and photo provided; however, it appears even with previously documented treatment records an animal was released within the withdrawal time as indicated on the approved label and your treatment record. This response does not contain any supporting documents regarding your proposed voluntary corrections and record keeping practices.
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 Victoria Murray, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions about this letter, please contact Compliance Officer LCDR Victoria Murray at (313) 393-8173 or email at Victoria.Murray@fda.hhs.gov.
Art O. Czabaniuk
Detroit District Office