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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Marlen Martin Farm 01-Aug-05

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




August 23, 2005

WARNING LETTER
(2005-DT-17

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

 

Mr. Marlen L. Martin, Owner
Marlen Martin Farm
22151 County Road 40
Goshen, IN 46526-0222

Dear Mr. Martin:

A tissue residue report received by the Food and Drug Administration (FDA) from -the~United States Department of Agriculture (USDA) reported the presence of an illegal residue in a cow owned by your firm. A subsequent investigation of your dairy operation located at 22151 State. Road 40, Goshen, Indiana, conducted by a representative of the FDA on April 21, 2005, confirmed that-you offered an animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. 342 (a)(2)(C)(ii)j and 402(a)(4) [21 U.S.C. 342 (a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). In addition, you adulterated an animal drug within the meaning of section 501(a) of the Act [21 U.S.C. 351(a)]. You can find the act FDA's web page at www.fda.gov.

On or about December 15, 2004, you sold a dairy cow for slaughter as food through [redacted] where it was given back tag number 4225. On or about December 29, 2004, this animal was slaughtered at the [redacted]. The United States Department of Agriculture, Food Safety and Inspection Service (USDAIFSIS) analysis of tissue samples collected from that animal identified the presence of [redacted] gentamicin in the kidney tissue of the dairy cow. Gentamicin is not approved for use in the bovine species except as a topical spray. No tolerance has been established for residues of gentamicin in the edible tissues of bovine species. Title 21, Code of Federal Regulations. Part
556.300 (21 C.F.R. 556.300).

A food is adulterated under section 402(a)(2)(C)(ii) of the Act if it bears or contains a new animal drug that is unsafe within the meaning of section 512. Your use of the drug contrary to the approved labeling is permitted only on the lawful order of a licensed veterinarian within the context of a valid veterinarian-client-patient relationship and in conformance with the criteria set forth in 21 CFR Part 530, including that there be no residue which may present a risk to human health. Because your use of gentamicin sulfate, resulted in the presence of a drug residue in edible tissue that might present a risk to human health, use of the drug was not in compliance with extralabel use regulations. 21 CFR 530.11(c). In addition, your use of the drug was not on the order of a veterinarian within the context of a valid veterinarian-client-patient-relationship. 21 CFR 530.10. The drug is therefore unsafe under section 512 of the Act, which causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [(21 U.S.C. 342(a)(2)(C)(ii)].

A food is also adulterated under section 402(a)(4) of the Act "if it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health." As it applies in this case, "insanitary conditions" means that you hold animals which are ultimately offered for sale for slaughter as food under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. Our investigation found that you lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate from edible tissues. For example, you failed to maintain treatment records, you failed to have an adequate system in place to segregate treated animals, and you lack an adequate inventory system for determining the quantities of drugs used to medicate your animals. 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)].

In addition, you adulterated the drug Gentocin (gentamicin sulfate) within the meaning -of section 501(a)(5) when you failed to use the drug in conformance with its approved labeling or the extralabel use regulations at 21 CFR Part 530. Your use of the drug contrary to the approved labeling and without conforming to extralabel use regulations causes the drug to be unsafe under section 512 of the Act and this adulterated under section 501(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 above violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.

You should take prompt action to correct the above violations and to establish procedures whereby such 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 with fifteen (15) working days, state the reason for the delay and the time frame within which the corrective will be completed. Please include copies of any available documentation demonstrating that corrective have been made.

Your written response should be sent to Ms. Judith Jankowski, Compliance Officer, U.S. Food and Drug Administration, Detroit District Office, 300 Rive rPlace; Suite 5900, Detroit, MI 48207. If you have any questions about this letter, please contact Compliance Officer Judith Jankowski at the above address.

Sincerely yours

/S/

JoAnn M. Givens
District Director
Detroit District