Inspections, Compliance, Enforcement, and Criminal Investigations
Robert Mitchell Farm 28-May-02
Department of Health and Human Services
Public Health Service
Atlanta District Office
May 28, 2002
VIA FEDERAL EXPRESS
Robert Mitchell, Owner
Robert Mitchell Farm
728 Mount Bethel Road
Harmony, North Carolina 28634
Dear W. Mitchell:
An investigation of your dairy operation by Investigator Richard L. Garcia on March 21 & 22, 2002, confirmed that you offered an animal for sale for slaughter as food, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). The animal was adulterated food within the meaning of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Act.
On or about December 4, 2001, you sold a cow, identified with tag [redacted] to [redacted] in [redacted]. This cow was sold for slaughter as human food to [redacted] on or about the same date. The United States Department of Agriculture (USDA)/Food Safety and lnspection Service (FSIS) analysis of tissue collected from that animal (Case No. 8-1789-01) disclosed the presence of the drug gentamicin in the kidney and liver tissue.
There is no allowable tolerance established for residues of gentamicin in the edible tissues of cattle (21 CFR 556.300). The presence of this drug in edible tissue 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 system for assuring that animals have been treated only with drugs which have been approved for use in those species; for assuring that drugs are used in a manner not contrary to the directions contained in the labeling; and for assuring that animals medicated by you or your employees have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. Investigator Garcia found that you had no animal medication records that would identify which animal had been medicated, what type of medication had been used, and what the withdrawal times should be. Food from animals held under such conditions is adulterated within the meaning of Section 402(a)(4) of the Act.
The above-identified violations are not intended to be an all-inclusive list of deficiencies at your dairy farm. Investigator Garcia issued a list of Inspectional Observations (FDA 483) to you at the conclusion of his visit. As a producer of animals offered for use as food, you are responsible for assuring that your overall operation and the foods you distribute are in compliance with the law.
You should take prompt action to correct the above and to establish procedures whereby such violations do not recur. Failure to do so may result in enforcement action being initiated by the FDA without further notice such as seizure and/or injunction.
You should be aware that it is not necessary for you to have personally shipped 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 and subsequently offered for We to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for a violation of the Act.
Please notify this office in writing within fifteen (15) working days of receipt of this letter as to the specific steps you have taken to correct the stated violations. You should also include an explanation of each step taken to identify and make corrections to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be implemented.
Your reply should be sent to the attention of Philip S. Campbell, Compliance Officer, at the address noted in the letterhead.
Ballard H. Graham, Director