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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Emanuel J. Lantz 6/25/13

  

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-23
 
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
June 25, 2013
                                                                                                     
 
Mr. Emanuel J. Lantz, Owner
525 W. Lime Rock Road
Lititz, Pennsylvania 17543-9045
 
Dear Mr. Lantz:
 
On April 10 and 16, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 525 W. Lime Rock Road, Lititz, Pennsylvania 17543-9045. 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 dairy 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 December 5, 2012, you sold a bob veal calf, identified with back tag #(b)(4), for slaughter as food. On or about December 5, 2012, (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 flunixin in the kidney tissue. FDA has not established a tolerance for residues of flunixin in the edible tissues of pre-ruminating calves.  The presence of this drug in edible tissue from this animal 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 provide identification for your animals. 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 FluMeglumine (flunixin meglumine, sterile injectable solution, ANADA #200-387). Specifically, our investigation revealed that you did not use FluMeglumine as directed by its approved labeling. Use of this drug 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)). 
 
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 FluMeglumine (flunixin meglumine, sterile injectable solution, ANADA #200-387) to a class of animal, bob veal calf identified with back tag #(b)(4), not set forth in the approved labeling. Your extralabel use of FluMeglumine was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a), and your extralabel use of FluMeglumine 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 the drug to beunsafe 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 Richard C. Cherry, Compliance Officer, U.S. Food and Drug Administration, 900 Customs House, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Compliance Officer Richard C. Cherry at (215) 717-3075 or email at Richard.Cherry@fda.hhs.gov.
 
 
Sincerely yours,
/S/
Kirk D. Sooter
District Director
Philadelphia District
 
Cc:      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. 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. Thomas Alexander
            Chief of Regulation and Compliance
            Pennsylvania Department of Agriculture
            Bureau of Animal Health
            Room 408
            2301 North Cameron Street
            Harrisburg, Pennsylvania 17120