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WARNING LETTER

RDJ Dairy Farm MARCS-CMS 505486 —

Product:
Animal & Veterinary

Recipient:
RDJ Dairy Farm


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
2016-DET-14
 
 
August 2, 2016
 
VIA UPS                                                         
 
Mr. Reid K. Morrison, Owner
RDJ Dairy
1272 Morrison Road
Rose City, Michigan 48654
 
Dear Mr. Morrison:
 
On May 17 and June 8, 2016, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1272 Morrison Road, Rose City, Michigan 48654. 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 August 31, 2015, you sold a culled dairy cow, identified with back tag # (b)(4) and ear tag #(b)(4) for slaughter as food. On or about September 1, 2015, (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 1.62 parts per million (ppm) in the kidney tissue. 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. The presence of the drug 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. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain complete 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).
 
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 your response, during the inspection, regarding the Form FDA 483 Inspectional Observations issued to you at the close of the above inspection. You provided a newly implemented “Drug Treatment Log” that lists the following: (b)(4). However, the treatment record is incomplete and is missing data. For example, (b)(4) is missing for Animal ID (b)(4)
 
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 July 2, 2015 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 August 31, 2015 you delivered a dairy cow identified with ear tag (b)(4) (subsequently identified with back tag #(b)(4)), which contained violative residues of desfuroylceftiofur to (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/ 
Art O. Czabaniuk
District Director
Detroit District Office