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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Hillcrest Dairy 8/12/14

  

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

Public Health Service
Food and Drug Administration
 

PHILADELPHIA DISTRICT
900 U.S. Customnouse
2nd and Chestnut Streets
Philadelphia, PA 19106

Telephone: 215-597-4390 

 

WARNING LETTER
14-PHI-19
 
 
OVERNIGHT MAIL
VIA UNITED PARCEL SERVICE                                                                              
 
August 12, 2014
 
 
Mr. Henry High, Co-Owner
Hillcrest Dairy
764 Spook Ln
Gettysburg, PA 17325-7905
 
Dear Mr. High:
 
On July 14-15, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 764 Spook Lane, Gettysburg, PA 17325. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation.  You can find the 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 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. Further, under section 402(a)(4) of the 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 August 14, 2013, you sold a dairy cow, identified with ear tag (b)(4) and later identified as back tag (b)(4) for slaughter as food. On or about August 14, 2013, (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, a metabolite of ceftiofur, at 0.62 parts per million (ppm) in the kidney tissue. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in the 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 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).
 
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 maintain and review treatment records and follow withdrawal timeframes. 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).
 
We acknowledge receipt of your response dated July 21, 2014, responding to the FDA-483, Inspectional Observations, issued on July 15, 2014. Your response is inadequate in that it is very vague and fails to include documentation on implemented corrections. FDA will verify the adequacy of your implemented corrections during our next inspection. 
 
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 Robin M. Rivers, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customs House, 200 Chestnut Street, Philadelphia, PA 19106. If you have any questions about this letter, please contact Ms. Rivers at (215) 717-3076 or email at robin.rivers@FDA.HHS.GOV.
 
Sincerely,
/S/ 
Anne E. Johnson
Acting District Director
Philadelphia District
 
cc:       
Mr. Reuben High, Co-owner
Hillcrest Dairy
764 Spook Ln
Gettysburg, PA 17325-7905
 
Piney Creek Veterinary Clinic
Dr. Donald Carman
4700 Piney Creek Road
Taneytown, MD 21787
 
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