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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Paul K Katzmaier 1/28/13

  

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-09
 
 
CERTIFIED MAIL 
RETURN RECEIPT REQUESTED
 
January 28, 2013
 
Mr. Paul K. Katzmaier, Owner
521 Katzmaier Road
Montoursville, Pennsylvania 17754
 
Dear Mr. Katzmaier:
 
On November 29, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 521 Katzmaier Road, Montoursville, Pennsylvania. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that were 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 August 16, 2012, you sold a bob veal calf, identified with sale tag (b)(4), for slaughter as food. On or about August 17, 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 neomycin at 20.38 parts per million (ppm) in the kidney. FDA has established a tolerance of 7.2 ppm in the kidney for residues of neomycin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.430(b)(1) [21 C.F.R. § 556.430(b)(1)]. However, this tolerance does not apply to the use of (b)(4) in bob veal calves, and there is no acceptable level of residue associated with the use of this (b)(4) in veal 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 complete treatment records and to segregate treated 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 drugs neomycin and oxytetracycline. Specifically, our investigation revealed that you did not use neomycin and oxytetracycline as directed by their approved labeling. Use of these drugs in this manner is an extralabel use. 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 (b)(4) containing neomycin and oxytetracycline to your bob veal calf identified with sale tag (b)(4) without following the animal class as stated in the approved labeling. Your extralabel use of neomycin and oxytetracycline was in or on feed, in violation of 21 C.F.R. 530.11(b) and your extralabel use of neomycin resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). 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, the drugs were 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).   
 
In addition, you adulterated the animal feed, (b)(4) within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6)], when you failed to use this medicated feed in conformance with its approved labeling. Your use of this medicated feed without following the animal class as directed by the approved labeling caused this medicated feed to be unsafe within the meaning of section 512 of the FD&C Act, 21 U.S.C. § 360b. Section 512 of the FD&C Act, 21 U.S.C. § 360b], and 21 C.F.R. 530.11(b) do not permit the extralabel use of medicated feeds.
 
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 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 timeframe 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 Robin M. Rivers, Compliance Officer, U.S. Food and Drug Administration, U.S. Customhouse, Room 900, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Ms. Rivers at 215-717-3076 or robin.rivers@fda.hhs.gov.
                                                                       
Sincerely,
/S/ 
Kirk D. Sooter
District Director
Philadelphia District
 
 
cc:      
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, NE 68102      
 
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