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  5. Vernon W. Zimmerman - 08/06/2014
  1. Warning Letters

WARNING LETTER

Vernon W. Zimmerman

Product:
Animal & Veterinary

Recipient:
Vernon W. Zimmerman


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
14-PHI-17
 
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
August 6, 2014
 
 
Mr. Vernon W. Zimmerman, Owner
715 East Main Street
New Holland, Pennsylvania 17557
 
Dear Mr. Zimmerman:
 
On December 5, 12, and 20, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your calf raising operation located at 243 Witmer Road, East Earl, Pennsylvania 17519. 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 drugs Neo-Sol 50 (neomycin sulfate, antibacterial, ANADA #200-180), Baytril 100 (enrofloxacin, antimicrobial injection, NADA #141-068), and Oxytet (oxytetracycline hydrochloride, soluble antibiotic, NADA #130-435). Specifically, our investigation revealed that you did not use Neo-Sol 50, Baytril 100, and Oxytet as directed by their prescription labels or approved labeling. Use of these drugs in this manner is an extralabel use. See 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 Neo-Sol 50 (neomycin sulfate, antibacterial, ANADA #200-180), Baytril 100 (enrofloxacin, antimicrobial injection, NADA #141-068), and Oxytet (oxytetracycline hydrochloride, soluble antibiotic, NADA #130-435) to your bob veal calves without following their recommended animal class (do not use in claves to be processed for veal), and slaughter withdrawal times as stated by the approved labeling. Your extralabel use of these drugs was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a). Also, Baytril 100 is prohibited for extralabel use in food producing animals by 21 C.F.R. 530.41(a)(10). 
 
In addition, you adulterated the animal feed that you fed to your calves by adding the new animal drugs Neo-Sol 50 (neomycin sulfate, antibacterial, ANADA #200-180) and Oxytet (oxytetracycline hydrochloride, soluble antibiotic, NADA #130-435) to the milk that was fed to your calves, within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. 351(a)(6). The extralabel use of drugs in or on animal feed is specifically prohibited by section 512(a)(4), 21 U.S.C. § 360b(a)(4), of the FD&C Act, and 21 C.F.R. Part 530.11(b).  
 
Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs 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 e-mail at robin.rivers@fda.hhs.gov.
 
 
Sincerely,
/S/ 
Anne E. Johnson
Acting District Director
Philadelphia District Office
 
 
cc:       
Dr. Jeffrey L. Pyle, DVM
 Manchester Veterinary Clinic, P.C.
11798 N. State Road 13
N. Manchester, Indiana 46962-8768
           
Daniel E. Gutman, Co-Owner
Gutman Brothers Ltd.
6105 Ivy Mount Road
Baltimore, Maryland 21209
 
Benjamin Z. Gutman, Co-Owner
Gutman Brothers Ltd.
6105 Ivy Mount Road
Baltimore, Maryland 21209
 
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