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WARNING LETTER

Cool Lawn Holsteins LLC

Product:
Animal & Veterinary

Recipient:
Cool Lawn Holsteins LLC


United States

Issuing Office:
Baltimore District Office

United States


   

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

Public Health Service
Food and Drug Administration
 
Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21201-2199
Telephone: (410) 779-5455
FAX: (410) 779-5705

 

WARNING LETTER
CMS #490094
 
February 22, 2016
 
Mr. Ken K. Smith, Owner
Cool Lawn Holsteins, LLC
11241 Merry Run Lane
Remington, VA 22734-2041
 
Dear Mr. Smith:
 
On January 19 & 21, 2016, The U.S. Food and Drug Administration (FDA) conducted an inspection of your dairy farm located at 11241 Merry Run Lane, Remington, VA 22734-2041. This letter notifies you of the violations of the Federal Food, Drug and Cosmetic Act (the Act) that we found during our inspection of your operation. You can find the Act and its associated regulations on the Internet through links on the FDA’s web page found at 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 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 Act, 21 U.S.C. §360b.
 
Specifically, our investigation revealed that on or about September 28, 2015, you offered a cow, identified as (b)(4) to slaughter for food to (b)(4), identified cow (b)(4) with back tag (b)(4) which was sold the same day to (b)(4).
 
USDA/FSIS analyses of tissues collected from that animal on September 29, 2015, at (b)(4) disclosed the presence of the drug desfuroylceftiofur (metabolite of Ceftiofur) at a level of 0.73 parts per million (ppm) in the kidney tissue. A tolerance of 0.4ppm has been established for residues of Ceftiofur in the edible kidney tissue of cattle per Title 21 Code of Federal Regulations Section 556.113. The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. §342 (a)(2)(C)(ii).
 
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 addressed to Ms. Evelyn Bonnin, District Director, Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, MD, 21215. If you have any questions regarding this letter, please contact CDR Rochelle B. Young, RPh, MSA, Compliance Officer, at 410-779-5437 or at rochelle.young@fda.hhs.gov.
 
Sincerely,
/S/ 
Evelyn Bonnin
District Director
Baltimore District