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WARNING LETTER

DeGrave Dairy MARCS-CMS 515987 —

Product:
Animal & Veterinary
Recipient:
DeGrave Dairy

United States

Issuing Office:
Minneapolis District Office

United States

 

   

Black HHS-Blue FDA Logo

 

 
 
Minneapolis District
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
(612) 334-4100 

 

February 27, 2017
 
 
WARNING LETTER
 
 
Via UPS Overnight Delivery                                                        Refer to MIN 17 – 05
 
 
Dale A. and Peggy DeGrave
Owners
DeGrave Dairy
E2471 County Road X
Casco, Wisconsin 54205
 
Dear Mr. and Mrs. DeGrave:
 
On September 21, October 28, and November 9, 2016, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dairy operation located at E2471 County Road X, Casco, Wisconsin. This letter notifies you of violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our inspection 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 April 11, 2016, you sold a dairy cow identified with your bangle tag (b)(4) for slaughter as food.  On or about April 14, 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 at 0.086 parts per million (ppm) in the kidney.  FDA has established a tolerance of 0.05 ppm for residues of penicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, section 556.510 (21 CFR 556.510). 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 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 failed to maintain records regarding the identity of animals that you transported and delivered for sale at an auction yard.  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 new animal drugs penicillin G procaine injectable suspension ((b)(4), NADA (b)(4)), cephapirin sodium intramammary infusion ((b)(4), NADA (b)(4)), and lincomycin-spectinomycin water soluble powder ((b)(4), NADA (b)(4)). Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling.  Use of these drugs 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 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.
 
Specifically, our investigation found:
 
1.   You administered (b)(4) penicillin to a dairy cow without following the dosage as stated in the approved label.  Your cow number (b)(4), which weighed 1265 pounds at slaughter, was treated with an estimated 25 - 30 milliliters (ml) of penicillin on March 29 and March 31, 2016. This was approximately double the labeled dosage of 1 ml per 100 lbs. Also, you treated cow (b)(4) (and other cows) with penicillin for mastitis. In cattle, (b)(4) penicillin is approved only for treatment of bacterial pneumonia. Your extralabel use of (b)(4) penicillin was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a) and resulted in an illegal drug residue, in violation of 21 CFR 530.11(d).
 
2.   You administered (b)(4) cephapirin sodium for intramammary infusion to several cows, including, but not limited to, cow number (b)(4) (on April 1, 2, and 4 – 9, 2016) and cow number (b)(4) (on March 31, April 1, 2, 4, 6, 7, and 9, 2016). (b)(4) cephapirin sodium is labeled to be repeated only once, 12 hours after the first treatment. Furthermore, cows (b)(4) and (b)(4) were sold two (2) days after treatment, even though the drug’s labeling specifies a four (4) day withdrawal period. Your extralabel use of (b)(4) cephapirin sodium for intramammary infusion was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a).
 
3.   You administered (b)(4) lincomycin-spectinomycin water soluble powder (after mixing with saline or dextrose) intravenously to treat difficult cases of mastitis. (b)(4) is only approved for oral use in chickens. Your extralabel use of (b)(4) lincomycin-spectinomycin water soluble powder 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 did not comply with 21 CFR Part 530, you caused penicillin G procaine injectable suspension ((b)(4), NADA (b)(4)), cephapirin sodium intramammary infusion ((b)(4), NADA (b)(4)), and lincomycin-spectinomycin water soluble powder ((b)(4), NADA (b)(4)) 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 are 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 Timothy G. Philips, Compliance Officer, at the address in the letterhead.
 
Lastly, we would like to meet with you to discuss recordkeeping and drug treatment practices on your dairy farm. We propose the week of March 27-31, 2017, for this meeting. The meeting should take about an hour, and it will be held in our office at 250 Marquette Avenue, Suite 600, Minneapolis, Minnesota.   As the owners and top officials of DeGrave Dairy, we ask that you attend the meeting. (b)(6) herdsman), (b)(6), is also encouraged to attend. Please telephone Mr. Philips at  (612) 758-7133 to schedule the meeting.
 
Sincerely,
/S/ 
Michael Dutcher, DVM
Director
Minneapolis District
 
 
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