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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Lynn Born 8/21/14

  

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

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128 

 

August 21, 2014
 
2014-DAL-WL-17
 
WARNING LETTER
 
UPS Overnight
 
Lynn Born, Owner
14520 Highway 305
Follett, Texas 79034
 
Dear Mr. Born:
 
On June 11-12, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your farm located at 14520 Highway 305, Follett, Texas 79034. 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 operation. You can find the 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 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 February 25, 2014, you sold a beef cow, identified with ear tags (b)(4) and (b)(4), for slaughter for food. On or about February 25, 2014, the cow with ear tags (b)(4) and (b)(4) was slaughtered at (b)(4).  The United States Department of Agriculture, Food Safety and Inspection Service’s (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 1.67 parts per million (ppm) of sulfamethazine in the liver and 0.054 ppm of penicillin in the kidney. FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.670 (21 C.F.R. 556.670). FDA has established a tolerance of 0.05 ppm for residues of penicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.510 (21 C.F.R. 556.510). The presence of these drugs in uncooked edible tissue from this animal in this amount 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 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. 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).
 
Our investigations also revealed that on February 25, 2014, you provided (b)(4), a signed certification stating 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 (b)(4).  On February 25, 2014, you delivered a beef cow identified with ear tags (b)(4) and (b)(4), which contained violative residues of penicillin and sulfamethazine, 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.
 
We have reviewed your response dated June 13, 2014, and it is inadequate. Although you state you will no longer sell treated animals who do not improve for slaughter; you still must maintain records of treatments for animals. Subsequently, your response states you will maintain records of treated animals. However, you do not include what information will be included in the records or provide examples of records to show implementation of treatment records.
 
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 Jeff R. Wooley, Compliance Officer, U.S. Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about this letter, please contact Compliance Officer Jeff R. Wooley at 214-253-5251.
 
 
Sincerely,
/S/ 
Reynaldo R. Rodriguez Jr.,
Dallas District Director
 
 
cc:      
Texas Department of State Health Services
Lewis Ressler
Food Program Manager
Exchange Building
8407 Wall Street
Austin, TX 78754
 
FSIS District Office 40
Attn: Dr. Jennifer Beasley-McKean, DM
1100 Commerce Street, Room 516
Dallas, TX 75242-0598
 
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