Inspections, Compliance, Enforcement, and Criminal Investigations

Poeppelman Pork LLC 2/5/15

  

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

Public Health Service
Food and Drug Administration
 
Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2775

 

February 5, 2015
 
 
WARNING LETTER
CIN-15-449511-13
 
 
Mr. Jay T. Poeppelman, Co-Owner
Mr. Kyle E. Poeppelman, Co-Owner
Poeppelman Pork, LLC
9886 State Route 705
Yorkshire, Ohio 45388
 
Dear Messrs. Poeppelman:
 
On November 5 and 10, 2014, the Food and Drug Administration (FDA) conducted an investigation of your swine farm operation located at 10341 Holthaus Road, Fort Loramie, Ohio. This letter notifies you of 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 February 13, 2014, you sold a sow identified with back tag (b)(4) for slaughter as food.  On or about February 17, 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 penicillin in the kidney. FDA has not established a tolerance for residues of penicillin in the edible tissues of swine as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.110 (21 C.F.R. 556.110). The presence of this drug in edible tissues from this animal in these amounts 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 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 Agri-Cillin (Sterile Penicillin G Procaine Injectable Suspension U.S.P., NADA 065-010). Specifically, our investigation revealed that you did not use Agri-Cillin as directed by its approved labeling.  Use of this drug in this manner is an extralabel use.  See 21 § C.F.R. 530.3(a).
 
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 Agri-Cillin to a sow with back tag (b)(4) without following the indication for use as stated in the approved label. Your extralabel use of Agri-Cillin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a) and your extralabel use of Agri-Cillin resulted in an illegal drug residue, in violation of 21 C.F.R. § 530.11(c). 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 this 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).
 
We note your response received in our office on November 21, 2014. Your response did not provide documentation demonstrating the corrections that have been made.
 
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 are in compliance with the law. 
 
You should take prompt action to correct the violations described in this letter and 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 timeframe within which the corrections will be completed.  Please include copies of any available documentation demonstrating that corrections have been made.
 
Please send your reply to the Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237, Attention: Allison Hunter. If you have any questions about this letter, please contact Compliance Officer Hunter at (513) 679-2700 ext. 2134 or by email at allison.hunter@fda.hhs.gov.
 
 
Sincerely yours,
/S/ 
Stephen J. Rabe
Acting District Director
Cincinnati District
 
CC:       
         Dr. Toney Forshey, Chief
         Ohio Department of Agriculture
         Division of Animal Health
         8995 East Main Street
         Reynoldsburg, OH 43068-3399

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