Inspections, Compliance, Enforcement, and Criminal Investigations

Dietsche's Dairy 12/7/16

  

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

Public Health Service
Food and Drug Administration
 Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142

 

December 7, 2016
 
 
WARNING LETTER
 
 
Via UPS Overnight Delivery                                           
Refer to MIN 17 – 02
 
 
Marvin Dietsche, Co-Owner
Richard L. Dietsche, Co-Owner
Dietsche’s Dairy
N8278 County Road Y
Spencer, Wisconsin  54479-9085
 
Dear Messrs. Dietsche:
 
On August 17-18, 2016, the United States Food and Drug Administration (FDA) conducted an inspection of your facility located at W1036 26th Road, Spencer, Wisconsin. 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 the 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 March 7, 2016, you sold a lactating dairy cow with farm yellow ear tag (b)(4) (cross-referenced to back tag (b)(4)) for slaughter as food. On or about March 8, 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 0.317 parts per million (ppm) of sulfadimethoxine in liver tissue and the presence of 0.074 ppm of penicillin in kidney tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (21 CFR), 556.640(b)(1). FDA has established a tolerance of 0.05 ppm for residues of penicillin in uncooked edible tissues of cattle as codified in 21 CFR 556.510(a). 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. Specifically, you failed to maintain complete treatment records. Your treatment records lack dosage given, route of administration, and withdrawal time for meat and milk. 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).
 
We also found that you adulterated the new animal drugs (b)(4) (penicillin G procaine, NADA (b)(4)), (b)(4) (sulfadimethoxine injection 40%, ANADA (b)(4)), and (b)(4) (tulathromycin, NADA (b)(4)). Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling. The use of these drugs in this manner is extralabel use. See 21 CFR 530.3(a).
 
The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the 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 the lactating dairy cow identified with farm yellow ear tag (b)(4) (cross-referenced to back tag (b)(4)), without following the dosage, dosage per injection site, approved indicated use, or duration of treatment as stated in the approved labeling. According to your treatment records you medicated the cow identified as (b)(4) with (b)(4) for 13 days with the last treatment on 2/19/16 for foot rot with a dosage of 25 cc of penicillin in one injection site. The cow weighed 1265 lbs. per the Kill Sheet dated 3/8/16, and the drug labeling stated that the amount per injection site should not be more than 10 cc. Therefore, the proper dosage for a 1265 lbs. animal is 12.65 cc. The drug should not be administered more than five consecutive days. Additionally, penicillin is approved for use in cattle for pneumonia, not foot rot.  Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a), and your extralabel use of (b)(4) resulted in an illegal drug residue, in violation of 21 CFR 530.11(d). 
 
You also administered (b)(4) to this dairy cow without following the route of administration as stated in the approved labeling, in violation of 21 CFR 522.2220(d)(4). You administered the cow identified as (b)(4) with (b)(4) by injecting the drug intramuscularly. The drug labeling states the drug should be administered only by intravenous route. Extralabel use of (b)(4) is prohibited for lactating dairy cows by 21 CFR 530.41(a)(9). Your extra label use of (b)(4) resulted in an illegal drug residue, in violation of 21 CFR 530.11(d).
 
In addition, you routinely administer (b)(4) to your dairy cows without following the animal class as stated in the approved labeling.  You admitted treating lactating dairy cows with (b)(4) to treat pneumonia. According to the drug labeling, (b)(4) should not be used in female dairy cattle 20 months of age or older. Your extralabel use of this drug was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a).
 
Because your use of these drugs was not in conformance with their approved labeling and do not comply with 21 CFR Part 530, you caused the drugs to be unsafe under section 512(a) of the Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the 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.
 
Within 15 working days of receiving this letter you should notify this office in writing of the steps you have taken to bring your firm into compliance with the law. 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 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 Boun M. Xiong, Compliance Officer, at the address in the letterhead. If you have any questions about this letter, please contact Mr. Xiong at (414) 326-3976.
 
Sincerely,
/S/
Michael Dutcher, DVM
Director
Minneapolis District
 

Page Last Updated: 12/19/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English