Inspections, Compliance, Enforcement, and Criminal Investigations

Oberholtzer, Joseph N. 8/4/14

  

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: 21 5-597·4390 

 

 WARNING LETTER
14-PHI-14
 
Delivered Via United Parcel Service
 
August 4, 2014
 
 
Joseph N. Oberholtzer
658 Maple Grove Road
New Holland, PA 17557
 
Dear Mr. Oberholtzer:
 
On February 11, 2014 and March 18, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 658 Maple Grove Road, New Holland, Pennsylvania. 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 5, 2013, you sold a bob veal calf identified with back tag # (b)(4), for sale for slaughter as food. On or about August 6, 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 dihydrostreptomycin at (b)(4) parts per million (ppm) in the kidney. FDA has established a tolerance of 2.0 ppm for residues of dihydrostreptomycin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.200 (21 C.F.R. 556.200); however, (b)(4) is not approved for use in bob veal calves, and there is no acceptable level of residue for dihydrostreptomycin in bob veal calves. 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 fail to maintain treatment records. 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 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
 
 
cc:  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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