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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Glenville Farms 8/29/14

  

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
14-PHI-20
 
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
August 29, 2014
 
 
Mr. Andrew Laffey, Partner
Mr. Norman Laffey Jr., Partner
Glenville Farms
2084 Glenville Road
Cochranville, Pennsylvania 19330-1799
 
Dear Mr. Laffey:
 
On July 2 and 3, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm located at 2084 Glenville Road, Cochranville, Pennsylvania. 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 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 December 16, 2013, you sold a dairy cow, identified with back tag (b)(4), for slaughter as food. On or about December 16, 2013, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from the dairy cow with back tag (b)(4) identified the presence of desfuroylceftiofur (marker residue for ceftiofur) at 0.83 parts per million (ppm) in the kidney tissue. FDA has established a tolerance of 0.4 parts per million (ppm) for residues of desfuroylceftiofur in uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.113 (21 C.F.R. 556.113). 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) 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 failed to identify and segregate treated animals. 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).
 
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 Ms. Robin M. Rivers, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Ms. Rivers at (215)717-3076 or e-mail at robin.rivers@FDA.HHS.GOV.
 
 
Sincerely,
/S/ 
Anne E. Johnson
Acting District Director
Philadelphia District Office
 
 
cc: Dr. Billy Smith
       University of Pennsylvania Field Service
       382 W. Street Road
       Kennett Square, PA 19348
 
       Dr. David R. Griswold, Acting Director
       Pennsylvania Department of Agriculture
       Bureau of Animal Health and Diagnostic Services (BAHDS)
       2301 North 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
 
       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, NE 68102
 
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