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  5. Clayholm Farms, LLC. - 06/09/2015
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WARNING LETTER

Clayholm Farms, LLC. Jun 09, 2015

Clayholm Farms, LLC. - 06/09/2015

Product:
Animal & Veterinary

Recipient:
Clayholm Farms, LLC.


United States

Issuing Office:
Philadelphia District Office

United States


   

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

Public Health Service
Food and Drug Administration
  PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390 

 

WARNING LETTER
15-PHI-16
 
Delivered Via United Parcel Service
 
June 9, 2015
 
Leland R. Claypoole, Co-Partner
Roy C. Claypoole, Co-Partner
Clayholm Farms, LLC
222 Hillberry Road
Worthington, Pennsylvania 16262
 
Dear Messrs. Claypoole:
 
On April 16, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 166 Clayholm Lane, Worthington, Pennsylvania. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic FD&C 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 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 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 May 9, 2014, you sold a dairy cow, identified with back tag (b)(4), for slaughter as food. On or about May 9, 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 desfuroylceftiofur (marker residue for ceftiofur) at (b)(4) parts per million (ppm) in the kidney tissue. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113(b)(3)(i)  (21 C.F.R. 556.113(b)(3)(i)). The presence of this drug in kidney 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 FD&C Act, 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. 
 
For example, you fail to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).
 
We also found that you adulterated the new animal drug (b)(4) (ceftiofur crystalline free acid, (b)(4)). Specifically, our investigation revealed that you did not use (b)(4) as directed by its approved labeling. Use of this drug in this manner is an extralabel use, as defined under 21 C.F.R. 530.3(a). We have enclosed a copy for your reference.
 
The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. §§ 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.
 
Our investigation found that you administered (b)(4) to a dairy cow identified with back tag (b)(4) without following the withdrawal period as stated in the approved labeling. Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a), and resulted in an illegal drug residue, in violation of 21CFR 530.11(d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).
 
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 Richard C. Cherry, Compliance Officer, U.S. Food and Drug Administration, U.S. Customhouse, Room 900, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Mr. Cherry at (215)717-3075 or by e-mail at Richard.Cherry@fda.hhs.gov.
 
  
Sincerely,
/S/
Anne E. Johnson
Acting District Director
Philadelphia District
 
 
Dr. Isabel Arrington, Director TA/C
United States Department of Agriculture (USDA)
Food Safety and Inspection Service (FSIS)
Office of Policy and Program Development
1616 Capitol Avenue, Suite 260
Omaha, Nebraska 68102
 
Dr. David R. Griswold, Acting Director
Pennsylvania Department of Agriculture
Bureau of Animal Health and Diagnostic Services (BAHDS)
2301 Cameron Street
Harrisburg, Pennsylvania 17120
  
Dr. Thomas Alexander
Chief of Regulation and Compliance
Pennsylvania Department of Agriculture
Bureau of Animal Health
Room 408
2301 North Cameron Street
Harrisburg, Pennsylvania 17110


 

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