Inspections, Compliance, Enforcement, and Criminal Investigations
MCAA Land & Cattle LLC 8/19/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
300 River Place
Detroit, MI 48207
August 19, 2009
RETURN RECEIPT REQUESTED
Mr. Maurice Loehmer, President
MCAA Land & Cattle LLC
Monterey, IN 46960
Dear Mr. Loehmer:
On February 24 and March 12,2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 4639 North 400 East, Monterey, IN 46960. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the 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 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 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 August 09, 2008, you sold a cow, identified with back tag (b)(4) and house tag (b)(4) for slaughter as food. On or about August 11, 2008, (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 6.10 ppm of sulfadimethoxine in the liver tissues. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the edible tissues of cattle as codified in Title 21, Code of Federal C.F.R. 556.640 (21 C.F.R. 556.640). The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the 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 failed to maintain records regarding the identity of individual animals you sold for human consumption, Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the
Act, 21 U.S.C. 342(a)(4).
We also found that you adulterated the new animal drug sulfadimethoxine. Specifically, our investigation revealed that you did not use sulfadimethoxine as directed by its approved labeling. Use of this drug in this manner is an extralabel use. 21 C.F.R. 530.3(a).
The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 5l2(a)(4) and (5) of the 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 sulfadimethoxine to a cow assigned back tag (b)(4) without following the dose instructions as stated in the approved labeling. Your extralabel use of sulfadimethoxine was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of sulfadimethoxine resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11 (d).
Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug(s) to be unsafe under section 512(a) of the Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the 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 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.
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 Tina M, Pawlowski, Ph,D, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Detroit, MI 48207, If you have any questions about this letter, please contact Compliance Officer Pawlowski at (313) 393-8217, or by email at tina,pawlowski@fda,hhs,gov.
Detroit District Office