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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Miller, Andrew J. 22-Oct-08

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

Public Health Service
Food and Drug Administration

 

Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771


October 22, 2008

WARNING LETTER
CIN-09-39858-02

VIA FEDERAL EXPRESS
 

Andrew J. Miller, Owner
7111 State Route 514
Big Prairie, OH 44611

Dear Mr. Miller:

On July 22 and 29, 2008, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 7111 State Route 514, Big Prairie, OH 44611. 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 May 7, 2008, you sold a bob veal calf, identified with backtag [redacted] for slaughter as food. On or about May 8, 2008 [redacted] 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 26.27 ppm of Penicillin in the muscle tissue, 0.86 ppm of Penicillin in the liver tissue and 0.42 ppm in the kidney tissue. FDA has established a tolerance of 0.05 ppm for residues of Penicillin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.510 (21 C.F.R. 556.510). The presence of this drug in edible tissues from this animal in these amounts 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 treatment records; you failed to establish a system to control the administration of drug treatments to your animals; you failed to establish an adequate inventory system for determining the quantities of drugs used to medicate your cows and calves; and you fed milk from treated cows to calves intended for slaughter. 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).

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 Gina M. Brackett, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237. If you have any questions about this letter, please contact Compliance Officer Brackett at (513)679-2700 ext. 167 or at gina.brackett@fda.hhs.gov.

Sincerely yours,

/S/

Toniette K. Williams
Acting District Director
Cincinnati District

cc: [redacted]

David Simmons
Ohio Department of Agriculture
8995 East Main Street
Reynoldsburg, OH 43068-3399

Dr. Isabel Arrington, Director TA/C
United States Department of Agriculture (USDA)
Food Safety and Inspection Service (FSIS)
Suite 300 Landmark Center
1299 Farnam Street
Omaha, NE 68102