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  5. United Producers, Inc. - 05/21/2015
  1. Warning Letters

WARNING LETTER

United Producers, Inc.

Product:
Animal & Veterinary

Recipient:
United Producers, Inc.


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
2015-DET-11
 
VIA UPS
 
 
May 21, 2015
 
 
Dennis Bolling, President and Chief Executive Officer
United Producers,  Inc.
8351 N. High Street, Suite 250
Columbus, OH 43235
 
Dear Mr. Bolling:
 
On April 3, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your auction facility located in St. Louis, MI. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operations. You can find the Act and its associated regulations on the Internet through links on the FDA web page at www.fda.gov.
 
We found that United Producers, Inc., offered an animal for sale for slaughter as food that was adulterated.  Under section 402(a)(2)(C)(ii) of the 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 Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the 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 12, 2014, a Holstein bull calf was consigned for sale at your auction, identified with back tag (b)(4), RFID ear (b)(4), and ear tag (b)(4). This calf did not sell at auction. According to your Senior Regional Manager, when an animal does not sell your firm sends the animal to a slaughter facility to be sold on the rail. In this case, United Producers opted to send the calf to (b)(4) where on or about May 13, 2014, it was slaughtered for food.
 
United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 10.7 ppm florfenicol in the calf’s liver and 1.23 pm florfenicol in the calf’s muscle tissue. FDA has established a tolerance of 3.7 ppm for residues of florfenicol in the edible liver tissues of cattle and 0.3 ppm for residues of florfenicol in the edible muscle tissues of cattle, as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.283(b) (21 C.F.R. § 556.283(b)).
 
In addition, USDA/FSIS analysis of tissue samples collected from this animal also identified the presence of 1.72 ppm flunixin in the calf’s liver and 0.0277 ppm flunixin in the calf’s muscle tissue. FDA has established a tolerance of 125 ppb (0.125 ppm) for residues of flunixin in the edible liver tissues of cattle and 25 ppb (0.025 ppm) for residues of flunixin in the edible muscle tissues of cattle, as codified 21 C.F.R. § 556.286(b). 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 Act, 21 U.S.C. § 342(a)(2)(C)(ii).
 
Our investigation also found that United Producers, Inc., holds animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4). Specifically, United Producers, Inc., lacks a system to ensure that animals you send for slaughter as food have not been medicated or, if they have been medicated, to allow them to be withheld from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissues.
 
The above is not intended to be an all-inclusive list of violations. As a distributor 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 above violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice such as injunction. To avoid future residue violations you should take precautions such as:
 
1.    Implementing a system to determine whether animals you receive for auction have been medicated, with what drug(s), and the date the withdrawal period (if any) terminates; and
2.    Obtaining signed statements from the source of the animal(s), if you are told the animal is not medicated.
 
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, 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 Seri Essary, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, MI 48207. 
 
If you have any questions about this letter, please contact Compliance Officer Essary at 313-393-8150.
 
 
Sincerely,
/S/ 
Art O. Czabaniuk
District Director
Detroit District Office
 
 
cc:       
Mr. Scott J. Acker, Senior Regional Manager
United Producers, Inc.
7810 Croswell
St. Louis, MI 48880
 
 
Ms. Melanie A. Hart
Cervid and Reportable Disease Program Secretary
Michigan Department of Agriculture and Rural Development
Animal Industry Division
HartM1@Michigan.gov

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