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U.S. Department of Health and Human Services

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Enforcement Actions

Piedmont Dairy 15-Jan-08

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

Public Health Service
Food and Drug Administration

 

Atlanta District Office

60 8th Street, N.E.
Atlanta, Georgia 30309


January 15, 2008
 

VIA FEDERAL EXPRESS

WARNING LETTER
(08-ATL-03)

 

Dale L. Utter, Owner
Piedmont Dairy
P.O. Box 205
250 Piedmont Dairy Road
Moore, South Carolina 29369

Dear Mr. Utter:

An investigation of your dairy operation located at 250 Piedmont Dairy Road, Moore, South Carolina, was conducted by a representative of the U. S. Food and Drug Administration (FDA) on April 16-26, 2007. We also obtained additional evidence on September 14, 2007. Our investigation 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)] and 402(a)(4) [21 U.S.C. § 342 (a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). The investigation also revealed that you provided a false guaranty, a prohibited act under section 301(h) [21 U.S.C. 331(h)] of the Act. You can find the Act and its associated regulations on the Internet through links in FDA’s web page at www.fda.gov.

On or about December 14, 2006, you sold a dairy cow, identified with Back Tag #[redacted], Retain Tag #[redacted], for slaughter as food at [redacted], [redacted]. On or about December 14, 2006, [redacted] slaughtered this cow. By letter dated January 10, 2007, United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) notified you that an analysis of tissue samples collected from this animal identified the presence of 7.03 parts per million (ppm) of penicillin in the kidney tissue, 0.37 ppm of penicillin in the liver tissue, and 0.20 ppm of penicillin in the muscle tissue. A tolerance of 0.05 ppm has been established for residues of penicillin in the edible tissues of cows as codified in Title 21, Code of Federal Regulations, Part 556.510 (21 CFR 556.510). The presence of penicillin in the edible tissues from this animal in these amounts 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)] of the Act.

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. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain animal treatment records that assure drugs have been used only as directed and that appropriate withdrawal times have been observed prior to offering an animal for slaughter for human food. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) [21 U.S.C. § 342 (a)(4)] of the Act.

On or about December 14, 2006, you provided [redacted] with a signed certification, which states that you were not delivering to [redacted] any livestock having illegal levels of drug residues. On December 14, 2006, you delivered a culled dairy cow containing high levels of volatile penicillin residues to [redacted]. Pursuant to section 301(h) [21 U.S.C. 331(h)] of the Act, providing such a false guaranty is a prohibited act.

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.

In addition, we are aware that USDA/FSIS notified you by letter dated August 23, 2006, that a tissue residue sample collected from a dairy cow sold by your firm, marked with Back Tag #[redacted] and slaughtered on August 9, 2006, found the presence of penicillin in the kidney at 0.25 ppm.

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, 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 Philip S. Campbell, Compliance Officer, U.S. Food and Drug Administration, 60 8th Street, N.E., Atlanta, Georgia 30309. If you have any questions about this letter, please contact Compliance Officer Philip S. Campbell at (404) 253-1280.
 

Sincerely,

/S/

Mary Woleske
District Director
Atlanta District
 

cc: Dr. Daniel Lafontaine, Director
South Carolina Meat & Poultry Inspection Department
P.O. Box 102406
Columbia, South Carolina 29224