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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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The Maschhoffs, LLC 6/27/12

  

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

Public Health Service
Food and Drug Administration
 

Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863

June 27, 2012

WARNING LETTER
CHI -5 -12


CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Kenneth D. Maschhoff, Chairman
The Maschhoffs, LLC
18395 Post Oak Road
Carlyle, Illinois 62231-3017

Dear Mr. Maschhoff:

On May 23, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your hog operation located at 18395 Post Oak Road, Carlyle, Illinois.  This letter notifies you of the violation 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.

Specifically, our investigator revealed that on or about November 16, 2011, you sold a cull sow with ear tag # (b)(4) for slaughter as food.  On or about November 18, 2011, (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 penicillin in the muscle and kidney tissue.  FDA has not established a tolerances for residues of penicillin in uncooked edible tissue of swine as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.510 (21 C.F.R. 556.510).  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 FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).

The above is not intended to be 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 compliant 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.

FDA acknowledges your firms response provided by Dr. Clayton L. Johnson during our inspection and the corrective actions implemented.

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 timeframe 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 Matthew Sienko, Compliance Officer, Food and Drug Administration, 550 W. Jackson Blvd., 15th floor, Chicago, IL  60661. If you have any questions about this letter, please contact Mr. Sienko at 312-596-4213.

Sincerely,

/S/

Scott J. MacIntyre
District Director