Public Health Service
Food and Drug Administration
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
June 30, 2016
Mr. John R. Moser, Owner
Morwai Dairy, LLC
P.O. Box 205
Fort Lupton, Colorado 80621-0205
Ref. #: DEN-19-09-WL
Dear Mr. Moser:
On April 4, 7, 13 and15, 2016, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy and heifer raising operation located at 19999 Weld County Rd 28, Hudson, Colorado 86014. 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 found that on or about January 20, 2016, you sold a dairy cow identified with ear tag (b)(4) for slaughter as food. On or about January 20, 2016, (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 2.04 parts per million (ppm) in the kidney tissue and flunixin at 0.673 ppm in the liver tissue. For cattle, FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in kidney tissue and 0.125 ppm for flunixin in liver tissue as codified in Title 21, Code of Federal Regulations (C.F.R.), Sections 556.113(b)(3) and 556.286(b)(1). The presence of these drugs in excess of the tolerance 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).
You also failed to maintain treatment records for the animal with ear tag number (b)(4). Specifically, your signed affidavit states that the Fresh Pen Treatment Logs are discarded after a (b)(4) period; further, although your signed affidavit states that the cow with ear tag number (b)(4) was treated at your dairy with (b)(4), there are no written treatment records specifically for this cow. 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 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 occur in the future. 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 response should be sent to U.S. Food and Drug Administration, P.O. Box 25087, Denver, Colorado 80225-0087, Attention: Matthew R. Dionne, PharmD, Compliance Officer. If you have any questions about this letter, please contact Dr. Dionne at (303) 236-3064.