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  5. Byron Kramer, Inc. - 09/28/2015
  1. Warning Letters

WARNING LETTER

Byron Kramer, Inc.

Product:
Animal & Veterinary

Recipient:
Byron Kramer, Inc.

United States

Issuing Office:
Denver District Office

United States


   

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

Public Health Service
Food and Drug Administration
  Denver District Office
Building 20 - Denver Federal Center
P.O. Box 25087
Denver, Colorado 80225-0087
TELEPHONE: 303-236-3000

 

September 28, 2015 
 
WARNING LETTER
 
 
VIA UPS Overnight
 
 
Ref: # DEN-15-15-WL 
 
Byron K. Kramer, Owner
Byron Kramer, Inc.
63454 County Road 4.5
Holyoke, Colorado 80734-9527
 
Dear Mr. Kramer:
 
 
On July 6, 7, and 8, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your cow/calf operation located at 63454 County Road 4.5, Holyoke, Colorado. 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 April 8, 2015, you delivered for sale a steer, identified with ear tag (b)(4), for slaughter as food. On or about April 9, 2015, (b)(4) slaughtered this animal. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of florfenicol at 6.52 parts per million (ppm) in the liver tissue; florfenicol at 2.07 ppm in the muscle tissue; and sulfamethazine at 10.12 ppm in the liver tissue. FDA has established tolerances of 3.7 ppm for residues of florfenicol in liver tissue of cattle and 0.3 ppm in muscle tissue of cattle, as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.283(b)(1) (i) and (ii) (21 C.F.R. 556.640(b)(1)(i) and (ii)). FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in uncooked edible tissues of cattle as codified in 21 C.F.R. 556.670. 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 and inventory for animal medications used by your firm. 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 drug (b)(4), NADA (b)(4)). Specifically, our investigation revealed that you did not use (b)(4) as directed by its approved labeling or veterinary prescription. Use of this drug in this manner is an extralabel use. See 21 C.F.R. 530.3(a). We have enclosed a copy for your reference.
 
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. § 360(b)(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 found that you administered (b)(4) to a steer identified with ear tag (b)(4) without following the withdrawal time as stated in the approved label. Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and resulted in an illegal drug residue in violation of 21 C.F.R. 530.11(d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug 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. 
 
We acknowledge receipt of your written response dated July 8, 2015. Although you state that you will keep copies of the treatment records in the farm vehicle to record treatments in the field, you failed to include documents showing your updated procedure for recording treatments. You also did not address how long you will maintain the treatment records to ensure medicated animals bearing potentially harmful residues will not enter the food supply. Furthermore, you did not address how you will maintain an inventory for all medications used by your firm.
 
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) business 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 Hanna L. Potter, Compliance Officer, U.S. Food and Drug Administration, P.O. Box 25087, Denver, Colorado 80225-0087. If you have any questions about this letter, please contact Ms. Potter at (303) 236-3094 or via email at hanna.potter@fda.hhs.gov.
 
Sincerely,
/S/ 
LaTonya Mitchell
District Director
Denver District
 
 
cc:       
Keith Roehr, DVM
Colorado State Veterinarian
305 Interlocked Pkwy
Broomfield, CO 80021
           
Anna Gallegos
Denver District Manager
USDA/FSIS
P.O. Box 25387
Denver, CO 80225
 
Mr. Donald Brown
Commissioner
Colorado Department of Agriculture
305 Interlocked Pkwy
Broomfield, CO  80021
 

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