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  1. Warning Letters

WARNING LETTER

Providence Dairy

Product:
Animal & Veterinary

Recipient:
Providence Dairy


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 

 

 April 7, 2015
 
WARNING LETTER
 
 
VIA UPS Overnight
 
Mr. George E. Vander Dussen
Owner
Providence Dairy
353 CR 19
Texico, New Mexico 88135
 
Ref: # DEN-15-09-WL
 
Dear Mr. Vander Dussen:
 
On February 10, 11 and 13, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 353 CR 19, Texico, New Mexico. 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 December 11, 2014, you sold a dairy cow, identified with back tag (b)(4)  and ear (bangle) tag (b)(4), for slaughter as food. On or about December 12, 2014, (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 1.51 parts per million (ppm) of desfuroylceftiofur in the kidney tissue. FDA has established a tolerance of 0.4 ppm desfuroylceftiofur (marker residue for ceftiofur) in kidney tissue as codified in Title 21, Code of Federal Regulations (CFR), Section 556.113(b)(3)(i) (21 CFR 556.113(b)(3)(i)). The presence of this drug in edible tissues from this animal in this amount 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 review said records to verify applicable withdrawal time prior to offering the animal for slaughter as food. 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 this drug product as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See 21 CFR 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 CFR 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 dairy cow, identified with back tag (b)(4)  and ear (bangle) tag (b)(4), without following indications for use as stated in the approved labeling.Your extralabel use of (b)(4)  was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Our investigation also found that you administered (b)(4)  to this same dairy cow without following the route of administration as stated in its approved labeling. Unapproved routes of administration for (b)(4) is prohibited in cattle by 21 C.F.R. 530.41(a)(13)(ii). Your extralabel use of (b)(4)  resulted in an illegal drug residue, in violation of 21 CFR 530.11(d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 CFR 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.
 
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 Sarah A. Della Fave, Compliance Officer, U.S. Food and Drug Administration, 6th Avenue & Kipling Street – Building 20 DFC, P.O. Box 25087, Denver, Colorado 80225-0087. If you have any questions about this letter, please contact Ms. Della Fave at (303) 236-3006 or via email at sarah.dellafave@fda.hhs.gov.
 
 
Sincerely,
/S/
LaTonya Mitchell
District Director
Denver District
  
cc:       (b)(4)
 
Dr. Jennifer Beasley-McKean
Dallas District Manager     
USDA/FSIS
1100 Commerce Street
Room 516
Dallas, TX 75242
 
Mr. Jeff M. Witte
Director/Secretary
New Mexico Department of Agriculture
MSC 3189, Box 30005
Las Cruces, NM 88003-8005

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