Inspections, Compliance, Enforcement, and Criminal Investigations

John D Ayars 1/13/16

  

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

Public Health Service
Food and Drug Administration
 
Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761

 

VIA UPS
 
January 13, 2016
 
Warning Letter
CIN-16-484836-06
                                                             
John D. Ayars, Owner
4381 Rosedale Road
Mechanicsburg, Ohio 43044-9403
 
Dear Mr. Ayars:
 
On September 28, October 5 and October 7, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 4381 Rosedale Road, Mechanicsburg, Ohio. 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 March 18, 2015, you sold a dairy cow identified with ear tag number (b)(4), for slaughter as food. On or about March 18, 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 ciprofloxacin and gentamicin in the kidney tissue. FDA has not established tolerances for residues of ciprofloxacin (marker residue for enrofloxacin) or gentamicin in the kidney of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.226(b)(1) and C.F.R. Section 556.300. Therefore, 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 complete permanent treatment records. 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.
 
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 Stephen J. Rabe, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Compliance Officer Rabe at 513-679-2700, ext. 2163 or stephen.rabe@fda.hhs.gov.
 
 
Sincerely,
/S/ 
Steven B. Barber
District Director
Cincinnati District
U.S. Food and Drug Administration

 

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