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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Mecklenburg Farm Inc 08-Mar-04

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

Public Health Service
Food and Drug Administration

 

555 Windedey Pl., Ste. 200
Maitland, Fl 32751


CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

FLA-04-22

March 8, 2004

Ingo Krieg, Owner
Mecklenburg Farm, Inc.
15551 West Beaver Street
Jacksonville, FL 32234

Dear Mr. Krieg:

An investigation of your dairy farm at the above address conducted by our investigators on October 8, 10, and 22, 2003, confirmed that you offered an animal for sale for slaughter as food in violation of sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), and that you have caused animal drugs to become adulterated within the meaning of section 501(a)(5).

On or about May 27, 2003 you sold a dairy cow, identified by back tag number [redacted] (bag tag [redacted] and listed as USDA/FSIS Case # [redacted] to [redacted] for slaughter as human food by [redacted]. USDA analysis of tissue samples collected from that animal identified the presence of penicillin in the kidney tissue at 0.17 parts per million (ppm). More recently, on January 14, 2004, USDA reported another tissue residue violation with the presence of 0.06 ppm penicillin in one of your dairy cows identified by ear tag [redacted]

A tolerance of 0.05 ppm has been established for residues of penicillin in the uncooked edible tissues of cattle. See Title 21, Code of Federal Regulations (C.F.R.), Section 556.510. The presence of this drug at levels above the established tolerance in the edible tissues from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act.

Our investigation also found that you hold animals under conditions that could allow medicated animals, bearing potentially harmful drug residues, to enter the food supply. For example, you lack an adequate record keeping system for assuring that animals which have been treated are withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from their edible tissues. The investigator found that you had no animal treatment/medication records from May 11 to May 30, 2003 that would identify which animal had been medicated, what type of medication had been used, and what the withdrawal times should be. You lack an adequate inventory system that would allow a comparison of the quantities of drugs on hand to the amounts of drugs actually used as recorded on the treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act.

This letter 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 assuring that your overall operation and the food you distribute are in compliance with the law.

You should take prompt action to correct these violations and to establish procedures to prevent their recurrence. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.

It is not necessary for you to personally ship an adulterated animal in interstate commerce to be responsible for a violation of the Act. The fact that you caused the adulteration of an animal that was sold to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for a violation of the Act.

Within fifteen (15) working days of receiving this letter, you should notify this office in writing of the specific steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step taken to correct the violations and prevent the recurrence of similar violations. If corrections cannot be completed within (15) working days, state the reason for the delay and the time frame within which the corrections will be completed. Also please include copies of any available documentation demonstrating that corrections have been made.

Your reply relating to these concerns should be directed to the U.S. Food and Drug Administration, Attention: Brant M. Schroeder, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding this letter, you may contact Mr. Schroeder by telephone at (407) 475-4763.

Sincerely,

/S/

Emma R. Singleton
Director, Florida District