Inspections, Compliance, Enforcement, and Criminal Investigations
H & H Farms 23-May-06
Department of Health and Human Services
Public Health Service
New Orleans District
May 23, 2006
WARNING LETTER NO. 2006-NOL-01
Richard S. Hunter, Owners
H & H Farms
2606 County Road 1564
Baileyton, AL 35019-9517
Dear Mr. Hunter:
On February 14, 15, March 16 and 22, 2006, an investigator from the United States Food & Drug Administration (FDA) conducted an investigation at your livestock operation, located at 2606 County Road 1564, Baileyton, Alabama. The investigation confirmed you offered an animal for sale for slaughter as food, which was adulterated under sections 402(a)(2)(C)(ii) [21 USC 342 (a)(2)(C)(ii)] and 402(a)(4) [21 USC 342 (a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and its associated regulations through links on the FDA's Internet home page at www.fda.gov.
On or about October 25, 2005, you sold a beef cow identified with Retain Tag [redacted] and Back Tag (BT) [redacted] for slaughter as food at [redacted]. On or about November 2, 2005 this animal was slaughtered at [redacted].The United States Department of Agriculture/Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of gentamicin in the kidney tissue of the cow. No tolerance has been established for residues of gentamicin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulation, 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 revealed you hold animals under such inadequate conditions the medicated animals bearing potentially harmful drug residues are likely to enter the food supply. You lack an adequate system to ensure medicated animals 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 drug treatment records of cattle offered for sale and sold for slaughter. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act [21 USC 342 (a)(4)].
The above is not intended to be an all-inclusive list of violations. As a producer/buyer/seller of animals offered for use as food, you are responsible for ensuring your overall operation and the food you distribute is in compliance with the law.
You should take prompt action to correct the above 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 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 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 corrections have been made.
Your written response should be sent to the U.S. Food and Drug Administration, Attention: Kimberly L. McMillan, Compliance Officer, 297 Plus Park Boulevard, Nashville, Tennessee 37217. If you have questions about this letter, please contact Ms. McMillan at (615) 781-5380, extension 138.
H. Tyler Thornburg
New Orleans District