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  5. Wingert Farms, Inc - 04/21/2015
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WARNING LETTER

Wingert Farms, Inc Apr 21, 2015

Wingert Farms, Inc - 04/21/2015

Product:
Animal & Veterinary

Recipient:
Wingert Farms, Inc


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-15
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
April 21, 2015
 
  
Mr. William J. Wingert, Owner
Wingert Farms, Inc.
5497 Shade Lane
Alexandria, Pennsylvania 16611-2737
 
Dear Mr. Wingert:
 
On January 20, 21, and 22, and February 2, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 5497 Shade Lane, Alexandria, 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 adulterated the new animal drug Prevail (flunixin meglumine) Injectable Solution, ANADA 200-308. Specifically, our investigation revealed that you did not use Prevail (flunixin meglumine) Injectable Solution, ANADA 200-308, as directed by its approved labeling or your servicing veterinarian’s written prescription. Use of this drug in this manner is an extralabel use, as defined under Title 21, Code of Federal Regulations (C.F.R.), Section 530.3(a) (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 Prevail (flunixin meglumine) Injectable Solution, ANADA 200-308, to your dairy cow, identified with ear tag (b)(4), without following the withdrawal period as stated in the approved labeling and your servicing veterinarian’s written prescription.  Your extra label use of Prevail (flunixin meglumine) Injectable Solution, ANADA 200-308, was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a).  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 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. Robin M. Rivers at (215) 717-3076 or by e-mail at robin.rivers@fda.hhs.gov.
 
Sincerely,
/S/ 
Anne E. Johnson
Acting District Director
Philadelphia District Office 
 
cc:       John E. Brockett, V.M.D.
            Huntingdon Veterinary Service
            100 Spruce Street
            Huntingdon, Pennsylvania 16652
 
            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, Nebraska 68102

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