Inspections, Compliance, Enforcement, and Criminal Investigations

Adrian Mortimer 8/15/17

 

  

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Office of Human and Animal Food Operations West Division 3
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204 

 
 

 

August 15, 2017
 
2017-DAL-WL-27
 
WARNING LETTER
 
UPS Overnight
 
Adrian J. Mortimer, Owner
1795 CR 430
Stephenville, Texas 76401
 
Dear Mr. Mortimer:
 
On May 2, 3 and 4, 2017, the U.S. Food and Drug Administration (FDA) conducted an investigation of your beef cattle operation located at 1795 CR 430, Stephenville, Texas 76401. 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 January 25, 2017, you sold a beef steer calf, identified with back tag (b)(4), for slaughter as food. On or about January 25, 2017, (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 residues, including penicillin at 1.193 parts per million (ppm) in kidney tissue; at 33.164 ppm in liver tissue;  and flunixin at 0.542 parts per billion (ppb)in liver tissue. You admitted to medicating the animal with these drugs before delivering to slaughter. The FDA has established a tolerance of 0.05 ppm for residues of penicillin in kidney tissue; and 0.125 ppb flunixin in the liver of cattle.  as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.510(a), 556.500 (b)(3),  556.670, and 556.286 (b)(1)(i). 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 for animals that you medicate; you had no inventory system for determining the quantities of drugs used to medicate your animals; you failed to maintain records regarding the identity of the animal(s) that you transport and deliver for slaughter; and you had expired drugs on your premises. 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 take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not reoccur. 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 January 25, 2017, you provided to (b)(4), a form titled “FDA Compliance for BSE and Drug Residue” that states that the animals presented for slaughter do not have an illegal level of drug residues. On or about January 25, 2017, you delivered a beef steer calf which contained violative residues of penicillin and flunixin, 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.
 
Our office is in receipt of your letter dated June 5, 2017, addressing the deviations noted on the Form FDA 483, Inspectional Observations, issued at the close of the inspection dated May 4, 2017. We have reviewed your response and find the corrective actions, in general, to be inadequate, as the response does not provide any representative documentation supporting your corrective actions and it does not address all deviations noted on the Form FDA 483. Specifically, you did not address the lack of treatment records and drug inventory, segregation of treated animals, and administration of prescription medications without the lawful written or oral order from a licensed veterinarian.
 
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 S. Alexander Hamblin, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about this letter, please contact Compliance Officer S. Alexander Hamblin at samuel.hamblin@fda.hhs.gov or 214-253-5240.
 
Sincerely,
/S/                                                           
Edmundo Garcia, Jr.
District Director
Program Division Director
Office of Human and Animal Food, WD3
                       
                                                           
 
cc:       FSIS District Office 40
            Attn: Dr. Jennifer Beasely-McKean, DM
            1100 Commerce Street, Room 516
            Dallas, Texas 75242-0598
           
            Texas Department of State Health Services
            1100 W. 49th Street
            Austin, Texas 78756
 

 

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