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  5. Peter & Dawn Erlwein - 03/09/2015
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WARNING LETTER

Peter & Dawn Erlwein

Product:
Animal & Veterinary

Recipient:
Peter & Dawn Erlwein


United States

Issuing Office:
New York District Office

United States


   

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
New York District
158-15 Liberty Avenue
Jamaica, NY 11433 

 

March 9, 2015
 
WARNING LETTER NYK-2015-26
 
 
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
                                                                                                     
Mr. Peter Erlwein, Co-Owner
Mrs. Dawn Erlwein, Co-Owner
112 Earl Myers Road
Jeffersonville, New York 12748
 
Dear Mr. and Ms. Erlwein:
 
On January 5, 14 and 16, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your cattle operation located at 112 Earl Myers Road, Jeffersonville, New York. 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 (b)(4), you sold a bob veal calf identified with ear tag (b)(4) (sale tag #(b)(4)) for slaughter as food. On or about (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 detected the presence of ciprofloxacin (metabolite of enrofolxacin) residue in the kidney tissue. FDA has not established a tolerance for residues of ciprofloxacin in the edible tissues of calves intended for slaughter for veal.  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 you failed to identify animals transported and delivered for sale at an auction yard. 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 (b)(4) (enrofolxacin, NADA (b)(4)).  Specifically, our investigation revealed that you did not use (b)(4) as directed by its approved labeling or veterinary prescription.  Use of the 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).
 
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) to a bob veal calf identified with back tag (b)(4) (sale tag (b)(4)) without following the slaughter class as directed in the approved labeling.  Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of (b)(4) resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). Your extralabel use of a fluoroquinolone ((b)(4)) in an unapproved production class is prohibited by 21 C.F.R. 530.41(a)(10). 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 LCDR Kristen C. Jackson, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Ave, Jamaica, New York 11433. If you have any questions about this letter, please contact LCDR Jackson at (718) 662-5711, or by e-mail at kristen.jackson@fda.hhs.gov.
 
  
Sincerely yours,
/S/
Ronald M. Pace         
District Director
New York District