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WARNING LETTER

Holdgrafer Dairy Inc. MARCS-CMS 518298 —

Product:
Animal & Veterinary
Recipient:
Holdgrafer Dairy Inc.

United States

Issuing Office:
Kansas City District Office

United States

 

   

Black HHS-Blue FDA Logo

 

 
 
Kansas City District Office
8050 Marshall Drive - Suite 205
Lenexa, Kansas 66214-1524
913-495-5100

 

March 2, 2017
 
WARNING LETTER
 
 
 
VIA UPS OVERNIGHT
 
Scott L. Holdgrafer, President and Owner
Holdgrafer Dairy, Inc.
20070 328th Ave. Bellevue, IA 52031
 
Ref: CMS 518298
 
  
Dear Mr. Holdgrafer:
 
On January 23-25, 2017, the Iowa Department of Agriculture and Land Stewardship (IDALS) conducted an investigation of your dairy operation located at 20070 328th Ave., Bellevue, IA 52031 on behalf of the U.S. Food and Drug Administration (FDA). 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 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 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 December 6, 2016 you consigned a cow, identified with ear tag number “162” and back tag number “ (b)(4),” for slaughter as food.  On  or about December 7, 2016, (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 penicillin in kidney tissue at a concentration of 0.651 parts per million (ppm) and the presence of dihydrostreptomycin in kidney tissue at a concentration of 92.79 ppm.  FDA has established a tolerance of (level) for residues of penicillin in the edible tissues of cows at 0.05 ppm as codified in Title 21, Code of Federal Regulations (CFR), Section 556.510(a) [21 C.F.R. § 556.510(a)]. FDA has established a tolerance of (level) for residues of dihydrostreptomycin in the edible tissues of cows at 2.0 ppm when sampled from the kidney as codified in Title 21, Code of Federal Regulations (CFR), Section 556.200 [21 C.F.R. § 556.200]. The presence of these drugs in edible tissue from this animal in these amounts 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 complete treatment records.  Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).
 
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 Victoria A. Wagoner, Compliance Officer, U.S. Food and Drug Administration, 8050 Marshall Drive, Suite 205, Lenexa, Kansas 66214. If you have any questions about this letter, please contact Compliance Officer Wagoner at: U.S. Food and Drug Administration, Kansas City District Office, 8050 Marshall Drive - Suite 205, Lenexa, Kansas 66214-1524, or by phone at 913-495-5150, or via email at Victoria.Wagoner@fda.hhs.gov.
 
 
Sincerely, 
/S/ 
Cheryl A. Bigham
District Director
Kansas City District
 
Cc:
 
Tricia Holdgrafer, Secretary, Treasurer, and Owner
Holdgrafer Dairy, Inc.
20070 328th Ave. Bellevue, IA 52031
 
And:
 
Randy Watts, Bureau Chief
Iowa Department of Agriculture and Land Stewardship (IDALS) Wallace Building
502 E. 9th Street
Des Moines, IA 50319
 
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