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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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James T. Blue & Sons, Inc. 9/5/13

  

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 

FEI: 3003239568

WARNING LETTER
CMS# 410959
 
September 5, 2013
 
CERTIFIED MAIL 
RETURN RECEIPT REQUESTED
 
Mr. Michael Blue, President
James T. Blue & Sons, Inc.
3364 Flowing Springs Road
Shenandoah Junction, WV 25442
 
Dear Mr. Blue:
 
An investigation of your cattle grower operation located in Shenandoah Junction, WV, conducted by the U.S. Food and Drug Administration (FDA) on May 28, June 3, and July 3, 2013 confirmed that you offered an animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov.
 
On or about February 27, 2013, you sold a bob veal calf, identified with (b)(4) for slaughter as food at (b)(4).  On or about February 28, 2013 this animal was slaughtered at (b)(4). United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of Neomycin at 43.01 parts per million (ppm) in the kidney tissue. A tolerance level of 7.2 ppm has been established for residues of Neomycin in the edible tissues of beef cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.430 (21 C.F.R. 556.430). 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) [21 U.S.C. 342(a)(2)(C)(ii)].
 
Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. You lack an adequate system to ensure that 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, you failed to maintain treatment records and you failed to have a system to control administration of drug treatments to your animals. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)].
 
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.
 
Your written response should be sent to Cherlita Honeycutt, Compliance Officer, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions about this letter, please contact Compliance Officer Honeycutt at (410) 779-5412 or Cherlita.Honeycutt@fda.hhs.gov.
 
Sincerely yours,
/S/ 
Evelyn Bonnin
District Director
Baltimore District
 
cc:        Scott E. Seebohm, DVM
            Deputy Director
            USDA/FSIS
            Policy Development Division
            1616 Capitol Avenue, Suite 260
            Omaha, NE 68102
           
            Jewell Plumley, DVM
            State Veterinarian/Director Animal Health
            WVDA – Moorefield Field Office
            60B Moorefield Industrial Park Road
            Moorefield, WV 26836