Inspections, Compliance, Enforcement, and Criminal Investigations
Smith Dairy 06-Jul-05
Department of Health and Human Services
Public Health Service
New Orleans District
July 6, 2005
WARNING LETTER NO. 2005-NOL-28
Samuel O. Smith, Owner
2220 Charlie Thomas Road
Cornersville, TN 37047-5011
Dear Mr. Smith:
On May 12-13, 2005, a U.S. Food and Drug Administration (FDA) investigator conducted an inspection of your dairy operation, located at 2220 Charlie Thomas Road, Cornersville, Tennessee. This inspection confirmed you offered an animal for sale as food which was adulterated within the meaning of Section 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). A food is adulterated under 402(a)(2)(C)(ii) of the Act if it contains a new animal drug which is unsafe within the meaning of Section 512 of the Act. You also caused the adulteration of a new animal drug, per Section 501(a)(5) of the Act, because the drug was used in a manner which does not conform with its approved use or extralabel use; therefore, making it unsafe within the meaning of Section 512 of the Act. You can find this Act and associated regulations through links on FDA's Internet home page at www.fda.gov.
On or about February 15, 2005, you sold a dairy cow, identified with ear Tag [redacted] #61 TR8577, and Retain Tag #4819680, for slaughter as human food at[redacted]through a local cattle hauler, [redacted] U.S. Department of Agriculture (USDA) tissue analysis (sample number 44252) collected from the cow identified the presence of 01.10 parts per million (ppm) penicillin in the kidney tissue. A tolerance of 0.05 ppm has been established for residues of penicillin in the edible tissues of cattle per Title 21, Code of Federal Regulations (21 CFR), Part 556.510(a). The presence of penicillin at the reported levels in uncooked, edible tissue of this animal causes the food to be adulterated within the meaning of Section 402(a)(2)(C)(ii) of the Act.
You also caused the adulteration of the drug, penicillin, within the meaning of Section 501(a)(5) of the Act when you failed to use the drug in conformance with its approved labeling or on the order of your licensed veterinarian causes this drug to be unsafe within the meaning of Section 512 of the Act. An extralabel drug use is permitted only in conformance with all critera set forth in 21 CFR 530, including there is no residue above established tolerance levels. Since your extralabel use of penicillin resulted in the presence of a residue above the established tolerance, you failed to comply with the, extralabel use regulation 21 CFR 530.11(d). In addition, because your extralabel use of penicillin was not on the lawful order of a licensed veterinarian, you also failed to comply with 21 CFR 530.10. You caused the drug to be unsafe under Section 512(a) of the Act and, thus, adulterated the drug within the meaning of Section 501(a)(5) of the Act.
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 you are holding animals, ultimately offered for sale for slaughter as food, under conditions so inadequate, medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, our investigation found you lack a system to (1) assure drugs are used in a manner consistent with the directions listed on the labeling, and (2) assure 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. Food from animals held under such conditions are adulterated under Section 402(a)(4) of the Act.
This 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 your overall operation and the foods you distribute are 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.
It is not necessary for you to personally ship an adulterated animal in interstate commerce to be responsible for a violation of the Federal Food, Drug, and Cosmetic Act. The fact you caused the adulteration of an animal, which was sold and subsequently offered for sale to a slaughterhouse who ships in interstate commerce, is sufficient to hold you responsible for a violation of the Act.
Please respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken to correct the deviations, including an explanation of each step taken to prevent recurrence of similar violations. You should include in your response any useful information to assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect you to explain the reason for your delay and state when you will correct any remaining deviations.
Please send your reply to the U.S. Food and Drug Administration, Attention: Kari L. Batey, Compliance Officer, U.S. Food and Drug Administration, 297 Plus Park Boulevard, Nashville, Tennesse 37217. If you have questions concerning the violations noted, please contact: Ms. Batey at (615) 781-5380, extension 112.
H. Tyler Thornburg
New Orleans District