Inspections, Compliance, Enforcement, and Criminal Investigations

Stonegate Farms 1/20/15

  

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

Public Health Service
Food and Drug Administration
 Dallas District Office
4040 North Central Expressway
Suite 300
Dallas, Texas 75204 

 

January 20, 2015
 
2015-DAL-WL-011
 
  
WARNING LETTER
  
UPS OVERNIGHT
                                                                                                     
 
Joseph G. Osterkamp, Partner/Manager
Gerald J. Osterkamp, Partner
Nicolas M. Osterkamp, Partner
Mary Beth Osterkamp, Partner
Stonegate Farms Family Limited Partnership
770 CR 1038
Muleshoe, Texas 79347
 
Dear Messrs. and Ms. Osterkamp:
 
On October 28-29, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 770 CR 1038, Muleshoe, Texas. 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 July 1, 2014, you sold a cow, identified with ear tag (b)(4) and back tag (b)(4), for slaughter as food.  On or about July 2, 2014, (b)(4), slaughtered this animal. 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 0.648 parts per million (ppm) of penicillin in the kidney and 9.44 ppm of sulfadimethoxine in the liver.  FDA has established a tolerance of 0.05 ppm for residues of penicillin in the edible tissues of cattle, as codified in Title 21, Code of Federal Regulations Part 556.510(a) (21 C.F.R. 556.510(a)). FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the edible tissues of cattle, 21 C.F.R. 556.640(b)(1). 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 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).
 
We also found that you adulterated the new animal drugs (b)(4) (sulfadimethoxine), (b)(4) and (b)(4) (penicillin G procaine), (b)(4). Specifically, our investigation revealed that you did not use (b)(4) and (b)(4) as directed by their approved labeling. Use of these drugs in this manner is an extralabel use. See 21 C.F.R. 530.3(a). 
 
The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.
 
Our investigation also found that you administered sulfadimethoxine to a cow with ear tag (b)(4) without following the withdrawal period as stated in the approved labeling. Sulfadimethoxine is prohibited for extralabel use in lactating dairy cattle by 21 C.F.R. 530.41(a)(9) and your extralabel use of sulfadimethoxine resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d).
 
Also, our investigation found that you administered penicillin G procaine to a cow with ear tag (b)(4) without following withdrawal period as stated in the approved labeling. Your extralabel use of penicillin G procaine was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a), and your extralabel use of penicillin resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d).   
 
Because your use of these drugs was not in conformance with their approved labeling, you caused the drugs to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).
 
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 Seri Essary, 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 Ms. Essary at 214-253-5335.
 
 
Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
Dallas District Director

Page Last Updated: 02/17/2015
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