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  5. O. Scott Wayment Dairy, Inc. - 497982 - 08/10/2016
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WARNING LETTER

O. Scott Wayment Dairy, Inc. MARCS-CMS 497982 —

Product:
Animal & Veterinary

Recipient:
O. Scott Wayment Dairy, 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 

 

August 10, 2016
WARNING LETTER
 
VIA UPS Overnight
 
Mr. O. Scott Wayment, Co-owner
O. Scott Wayment Dairy, Inc.
1568 N. 5900 W.
Ogden, UT 84404
Ref: DEN - 16 - 13 - WL
 
Dear Mr. Wayment:
 
On February 17, 19, and March 24, 2016, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation, O. Scott Wayment Dairy, Inc., located at 1568 North 5900 West, Ogden, Utah 84404-9061. 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 September 16, 2015, you sold a dairy cow identified with ear bangle tag (b)(4), for slaughter as food. On or about September 17, 2015, (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 5.710 parts per million (ppm) of penicillin in the kidney tissue. FDA has established a tolerance of 0.05 ppm for residues of penicillin in uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (CFR), Section 556.510(a) (21 C.F.R. 556.510(a)). The presence of this drug in 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 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. You stated that your practice was to record the animal ID and the date treated on a (b)(4) calendar and then discard the records at the end of the calendar year. The current treatment records dated 2016 failed to record the identity and amount of the drug administered, route of administration, and the meat and milk withdrawal times. 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) (penicillin G procaine injectable suspension, (b)(4)). Specifically, our investigation revealed that you did not use this drug as directed by its approved labeling and/or by a veterinarian’s prescription. Use of this drug 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 found that you administered (b)(4) (penicillin G procaine injectable suspension, (b)(4)) to a dairy cow identified with ear bangle tag (b)(4), without following the dosage level set forth in the approved drug labeling which states not to exceed (b)(4) units per pound of body weight or the equivalent of (b)(4) as the total daily dosage. Your initial treatment of cow with ear bangle (b)(4) (estimated to weigh 1600 lbs. or a maximum daily dosage of (b)(4)) was to administer penicillin at a rate of (b)(4). After waiting for one week, you extended the treatment of (b)(4) ending on September 9, 2015. Then without seeing any improvement, you sold her on September 16, 2015 for beef. Your extralabel use of the (b)(4) injectable suspension was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a), and your extralabel use of the (b)(4) injectable suspension 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.
 
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 Lauren Skokan Priest, Compliance Officer, U.S. Food and Drug Administration, 6th Avenue and Kipling Street – Building 20 DFC, P.O. Box 25087, Denver, Colorado 80225-0087. If you have any questions about this letter, please contact Compliance Officer Lauren Skokan Priest at (303) 236-9663 or by e-mail at lauren.skokan@fda.hhs.gov.
  
 
Sincerely,
/S/ 
LaTonya Mitchell
District Director
 
 
cc:       
Mr. Trevor D. Wayment, Co-Owner
O. Scott Wayment Dairy, Inc.
1568 North 5900 West
Ogden, Utah 84404-9061
 
Anna Gallegos, Denver District Manager
USDA/FSIS
Bldg 45, Door S3
PO Box 25387
1 Denver Federal Center
DFC, Building 45 S3
Denver, Colorado 80225
 
Ms. Luann Adams, Commissioner
Utah Department of Agriculture & Food
350 N. Redwood Road
P.O. Box 146500
Salt Lake City, UT 84414-6500

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