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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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De Saegher Cattle LLC 4/19/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

Detroit District
300 River Place
Suite 5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139 

 

WARNING LETTER
2012-DET-12

April 19, 2012


VIA UPS


Barthel J A De Saegher, Owner
De Saegher Cattle LLC
8068 W. Buchanan Road
Middleton, Michigan 48856


Dear Mr. De Saegher:

 


On March 20, 21, and 28, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 8068 W. Buchanan Road, Middleton, Michigan 48856. 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 July 22, 2011 you sold a cow identified with ear tag number (b)(4) and back tag (b)(4) for slaughter as food. On or about July 22, 2011, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of liver tissue collected from this animal identified the presence of sulfadimethoxine at a level of 0.287 parts per million (ppm). FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the liver tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.640 (21 C.F.R. 556.640). The presence of this drug in the edible tissue of this animal in this amount 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 March 28, 2012 regarding the FDA 483 Inspectional Observations issued to you at the close of the above inspection. Your response states that the dosing of the above animal was accidental and that you corrected this violation by removing the sulfadimethoxine drug from your farm. You also explained that you have put a new system in place that will include recording the diagnosis of the animal, drug administered, dosage, and route of administration. Additionally, you state that you have implemented a new system for the control of expired drugs, drug tracking and methods of dosage. However, we were unable to verify the corrections identified in your response because no actual documentation of these corrections was provided. For example your response did not include a copy of your new medication records or of the new system you described.


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 Michael V. Owens, 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 Owens at (313) 393-8167 or by email at michael.owens@fda.hhs.gov.


Sincerely yours,
/S/
Glenn T. Bass
District Director
Detroit District Office