Inspections, Compliance, Enforcement, and Criminal Investigations

Silas C. Lawhorn 3/12/15

  

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

Public Health Service
Food and Drug Administration
 Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5707 

 

WARNING LETTER
CMS#452086

March 12, 2015

Via UPS

Mr. Silas C. Lawhorn, Owner
Silas C. Lawhorn
2828 Old Country Road
Bedford, Virginia 24523
Dear Mr. Lawhorn:

On December 16 and 19, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your cattle farm located at 2828 Old Country Road, Bedford, Virginia 24523. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA's web page www.fda.gov.

We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

Specifically, our investigation revealed that on or about February 8th, 2014, you sold a beef cow identified with back tag# (b)(4) for slaughter as food. On or about February 11, 2014, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 2.914 parts per million (ppm) of tilmicosin residue in the muscle and 19.994 ppm of tilmicosin residue in the liver. FDA has established a tolerance of 0.1 ppm for residues of tilmicosin in the muscle and 1.2 ppm for residues of tilmicosin in the liver as codified in Title 21, Code of Federal Regulations CC.F.R.). Section 556.735, 21 C.F.R. 556.735, The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii).

Our investigation found the following violations: 

• Failure to inquire about the medication status of the animal(s) that you purchase and deliver for sale. You do not inquire about the medication status of purchased animals. 

• Administration of veterinary prescription drugs was performed without the lawful written or oral order of a licensed veterinarian. You administered the new animal drug (b)(4)(tilmicosin, (b)(4)) to your angus beef cow identified with ear tag # (b)(4) for pneumonia in early December, 2014 without a lawful written or oral order of a licensed veterinarian.

• You lack an adequate inventory system for determining the quantities of drugs used to medicate your livestock. You have no drug inventory system at your firm.

The above 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 ensuring that your overall operation and the food you distribute is in compliance with the law.

You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, 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 that corrections have been made.

Please send your written reply to the U.S. Food and Drug Administration, Attention: David P. Rice, Compliance Officer at the address above. If you have questions regarding any issues in this letter, please contact Mr. Rice by phone at 410-779-5463 or by email at david.rice@fda.hhs.gov.


Sincerely yours,
/S/
Evelyn Bonnin
District Director
Baltimore District Office
 

Page Last Updated: 06/29/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English