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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Elmer H. Zimmerman 7/16/13

  

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
13-PHI-25
 
July 16, 2013
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
Mr. Elmer H. Zimmerman, Owner
Elmer H. Zimmerman Dairy
15416 Kutztown Road
Kutztown, Pennsylvania 19530
 
Dear Mr. Zimmerman:
 
On June 18, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation at 15416 Kutztown Road, Kutztown, 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 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 27, 2013, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about February 28, 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 gentamicin in the kidney. FDA has not established a tolerance for residues of gentamicin in the edible tissues of cattle, including calves to be processed for veal. 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 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 treatment records and segregate treated dams from calves to be processed veal. 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 compounded drug containing the new animal drugs GentaMax 100 (gentamicin sulfate) Solution, ANADA 200-395, and FluMeglumine (flunixin meglumine) Injectable Solution, ANADA 200-387, as prepared by your servicing veterinarian. Specifically, our investigation revealed that you did not use the compounded drug containing GentaMax 100 (gentamicin sulfate) Solution, ANADA 200-395, and FluMeglumine (flunixin meglumine) Injectable Solution, ANADA 200-387, as directed by your servicing veterinarian’s written prescription. Use of this compounded drug in this manner is an extralabel use. For the definition of extralabel use, see Title 21, Code of Federal Regulations (C.F.R.), Section 530.3(a) (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 the compounded drug containing GentaMax 100 (gentamicin sulfate) Solution, ANADA 200-395, and FluMeglumine (flunixin meglumine) Injectable Solution, ANADA 200-387, to your dams and allowed calves to be processed for veal to suckle from these treated dams without following the withdrawal period as stated in your servicing veterinarian’s written prescription. Your extralabel use of the compounded drug containing GentaMax 100 (gentamicin sulfate) Solution, ANADA 200-395, and FluMeglumine (flunixin meglumine) Injectable Solution, ANADA 200-387, was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of a compounded drug containing GentaMax 100 (gentamicin sulfate) Solution, ANADA 200-395, and FluMeglumine (flunixin meglumine) Injectable Solution, ANADA 200-387, resulted in an illegal residue, in violation of 21 C.F.R. 530.11(c). Because your use of this compounded drug prepared by your servicing veterinarian was not in conformance with your servicing veterinarian’s written prescription and did not comply with 21 C.F.R. Part 530, you caused the compounded 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. Rivers at (215)717-3076 or e-mail at robin.rivers@FDA.HHS.GOV.
 
Sincerely,
/S/ 
Kirk D. Sooter
District Director
Philadelphia District Office