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  5. Parisville Dairy, LLC - 01/10/2014
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WARNING LETTER

Parisville Dairy, LLC

Product:
Animal & Veterinary

Recipient:
Parisville Dairy, LLC


United States

Issuing Office:
Detroit District Office

United States


   

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

Public Health Service
Food and Drug Administration
  Detroit District
300 River Place
Suite 5900
Detroit, Ml 48207
Telephone: 313·393·8100
FAX: 313·393·8139 

 

Warning Letter
2014-DET-04
January 10, 2014
 
VIA UPS                                                         
 
Mr. Denis M. Burke, Owner
Parisville Dairy, LLC
5301 Dodge Road
Cass City, Michigan 48726
 
Dear Mr. Burke:
 
On November 04 and 13, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 3657 Parisville Road, Ruth, Michigan 48470. 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 December 11, 2012, you sold a culled dairy cow, identified with back tag #(b)(4) and ear tag #(b)(4)  for slaughter as food. On or about December 12, 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 desfuroylceftiofur, a marker residue for ceftiofur, at 7.55 parts per million (ppm) in the kidney tissue and the presence of flunixin at 3.31 ppm in the liver and 0.0815 ppm in the muscle tissues. FDA has established a tolerance of 0.4 ppm for residues of ceftiofur in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113, 21 C.F.R. 556.113 and a tolerance of 0.125 ppm for residues of flunixin in the liver (target tissue) of cattle and .025 ppm in the muscle, as codified at 21 C.F.R. 556.286. The presence of these drugs in edible tissues from this animal in these amounts 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 we found expired animal drugs on-site. 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 Excede Sterile Suspension (Ceftiofur Crystalline Free Acid, NADA #141-209) and Prevail Injectable Solution (Flunixin Meglumine, ANADA #200-387). Specifically, our investigation revealed that you did not use Excede and Prevail as directed by their approved labeling or by the servicing veterinarian’s prescription. Use of these drugs in this manner is an extralabel use. See 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 Excede Sterile Suspension (Ceftiofur Crystalline Free Acid, NADA #141-209) and Prevail Injectable Solution (Flunixin Meglumine, ANADA #200-387) to your culled dairy cow identified with back tag # (b)(4) and ear tag # (b)(4) without following the withdrawal periods as stated on their approved labeling. Your extralabel use of Excede and Prevail was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of Excede and Prevail resulted in illegal drug residues, in violation of 21 C.F.R. 530.11(d). 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 these 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.
 
We acknowledge receipt of your written response dated November 15, 2013 regarding the Form FDA 483 Inspectional Observations issued to you at the close of the above inspection. Your response states that you have changed the way you record treatments including: now reinstating you handwritten treatment records in addition to the incomplete computer record; and review all treatment records prior to selling a cow. Additionally, you state that you are now looking at all drug labels for proper treatment regime, which includes dose, frequency, duration, and route of administration. We acknowledge the example medication record and photo provided; however, it appears even with previously documented treatment records an animal was released within the withdrawal time as indicated on the approved label and your treatment record.
 
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.
 
Our investigation also revealed that on or about August 9, 2011 you provided to (b)(4), a signed certification that states that the livestock you sell do not have illegal levels of drug residues. According to the certificate, it remains in effect until the undersigned delivers written notice of revocation to the (b)(4) market / staff. On or about December 11, 2012 you delivered a dairy cow identified with ear tag (b)(4) (subsequently identified with back tag # (b)(4)), which contained violative residues of desfuroylceftiofur and flunixin (b)(4). Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. § 331(h). You should take appropriate actions to ensure that this violation does not recur.
 
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 Kelli Wilkinson, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions about this letter, please contact Compliance Officer LCDR Kelli Wilkinson at (313) 393-8120 or email at Kelli.Wilkinson@fda.hhs.gov.
 
 
Sincerely yours,
/S/
Glenn T. Bass
District Director
Detroit District Office

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