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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Oak Grove Farm 3/12/13

  

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
Baltimore, MD  21201-2199
Telephone: (410) 779-5455
FAX: (410) 779-5705

 

Warning Letter
CMS #393849
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
March 12, 2013
 
Mr. Mike Edwards, Owner
Oak Grove Farm
660 Imogene Road
Lambsburg, VA 24351
 
Dear Mr. Edwards:
 
An investigation of your cattle grower operation located in Lambsburg, VA, conducted by a representative of the U.S. Food and Drug Administration (FDA) on January 22, 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).
 
On or about November 3, 2012, you sold a feeder heifer, identified with (b)(4), for slaughter as food at (b)(4). On or about November 8, 2012 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 44.69ppm of Oxytetracycline within the kidney tissue. A tolerance of 12ppm has been established for residues of Oxytetracycline in the edible tissues of beef cattle as codified in Title 21, Code of Federal Regulations, Part 556.500 (21 C.F.R. 556.500). 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 complete treatment records; you failed to segregate treated animals; you failed to observe withdrawal times and directions on drug label. 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 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.
 
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, 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 Ms. Evelyn Bonnin, District Director, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have any questions about this letter, please contact Compliance Officer CDR Rochelle B. young at 410-779-5437. 
 
Sincerely yours,
/S/
Evelyn Bonnin
Baltimore District Director