Inspections, Compliance, Enforcement, and Criminal Investigations
Phillip & Vincent Banks Dairy Farm 30-Sep-05
Department of Health and Human Services
|Public Health Service |
Food and Drug Administration
|New Orleans District|
297 Plus Park Blvd.
Nashville, TN 37217
September 30, 2005
WARNING LETTER NO. 20005-NOL-34
Mr. Phillip V. Banks, Co-Owner
Phillip and Vincent Banks Dairy Farm
201 Cortner Mill Road
Normandy, TN 37360-9713
Dear Mr. Banks:
An investigation of your dairy operation, located at 201 Cortner Mill Road, Normandy, Tennessee, conducted by a representative of the U.S. Food and Drug Administration (FDA) on June 30 and July 1, 2005, confirmed you offered an animal for sale for slaughter as food, which was adulterated under Sections 402(a)(2)(C)(ii) and 402(a)(4of the Federal Food, Drug, and Cosmetic Act (the Act). A food is adulterated under Section 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 can find the Act and its associated regulations on the Internet through links on the FDA web page at www.fda.gov.
On or about March 24, 2005, you sold for slaughter as food a dairy cow bearing Retain Tag # [redacted]. The cow was slaughtered as human food on March 29, 2005. The U.S. Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 2.01 part per million (ppm) gentamicin in the kidney tissue of the dairy cow. No tolerance has been established for residues of gentamicin in the edible tissues of bovine species as codified in Title 21, Code of Federal Regulations, Part 556.300 (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 you hold animals under such inadequate conditions that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. You lack an adequate system to ensure 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, your treatment records did not always include treatment dates, dosage used, and routes of administration. Food from animals held under such conditions is adulterated within the meaning of Section 402(a)(4) of the Act.
It is not necessary for you to have personally shipped an animal in interstate commerce to be responsible for a violation of the Act. The fact you caused the adulteration of an animal, which was sold and subsequently offered for sale to a slaughterhouse that ships in interstate commerce, is sufficient to hold you responsible for a violation of the Act.
This letter may not list all the deviations at your facility. You are responsible for ensuring your firm operates in compliance with the Act. You should take prompt action to correct these violations. Failure to promptly correct these deviations may result in regulatory action, including seizure and/or injunction without further notice.
Please respond in writing within fifteen (15) working days of your receipt of this letter outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include each step taken to correct the violations and prevent their recurrence. If you cannot complete all corrections within 15 working days, we expect you to explain the reason for the delay and state when any remaining deviations will be corrected.
Please send your reply to the U.S. Food and Drug Administration, Attention: Mark W. Rivero, Compliance Officer, 297 Plus Park Boulevard, Nashville, Tennessee 37217. If you have questions regarding the issues in this letter, please contact Mr. Rivero at (615) 695-4654, extension 113.
H. Tyler Thornburg
New Orleans District