WARNING LETTER

Dolezal Dairy MARCS-CMS 558107 — August 29, 2018

Product:: Animal & Veterinary

Recipient:: Recipient Name

Mr. Dolezal; Dolezal Dairy; 947 - 24th Road
Pender, NE 68047
United States

Issuing Office:: Kansas City District Office; United States

Office of Human and Animal Food-

West Division II

8050 Marshall Drive - Suite 205

Lenexa, Kansas 66214-1524

913-495-5100

August 29, 2018

WARNING LETTER

VIA UNITED PARCEL SERVICE

SIGNATURE REQUIRED

Refer to CMS Case # 558107

Mr. Jeffery A. Dolezal

Mr. Mark G. Dolezal

Mr. Mark R. Dolezal

Co-Owners

Dolezal Dairy
947 - 24th Road
Pender, Nebraska 68047

Dear Messrs. Dolezal

On June 5, 2018 and June 11, 2018, the United States Food and Drug Administration (FDA) conducted an inspection of your dairy operation, Dolezal Dairy, located at 947 - 24th Road Pender, Nebraska. This letter notifies you of violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that were revealed during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on the FDA’s web page at www.fda.gov.

Adulteration of an Animal Offered for Human Consumption:

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 March 22, 2018, you sold a cow for slaughter as food, with a green ear tag numbered (b)(4) on the front and on the back, (b)(4) and (b)(4)(cow with ear tag (b)(4)). You sold this cow at (b)(4) on March 22, 2018, and it was subsequently slaughtered on March 23, 2018 at (b)(4). The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of desfuroylceftiofur (marker residue for ceftiofur) at 8.649 parts per million (ppm) in kidney tissue. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (CFR), section 556.113 (21 C.F.R. § 556.113). 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. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain complete and accurate treatment records. Treatment records must include the condition being treated, dosage, route of administration, the person who administered treatment, and withdrawal times. Complete records should include this information, as well as diagnosis and indications for use. 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).

Adulteration of a New Animal Drug

We also found that you adulterated the new animal drug Excede™ (ceftiofur crystalline free acid, ANADA 141-209). Specifically, our investigation revealed that you did not use this drug as directed by its approved labeling. Use of this drug in this manner is an extra-label use, as defined by 21 C.F.R. § 530.3(a).

The extra label use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extra-label 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. Extra-label use of this drug, if not under the supervision of a licensed veterinarian, may cause additional violative drug residues.

Our investigation found you administered Excede™ (ceftiofur crystalline free acid) to a dairy cow with ear tag (b)(4) without following the indications for use and withdrawal time as stated in the approved labeling. You admitted to using Excede™ for unapproved uses including treating cow with ear tag (b)(4) with 18 mL of Excede™ (ceftiofur crystalline free acid) via a subcutaneously injection behind the ear for treatment of diarrhea and fever. Excede™ is not approved for treatment for diarrhea and fever. Also, you admitted to entering the wrong date in your calendar, which caused you to sell the cow with ear tag (b)(4) before the end of the meat withdrawal period specified in the approved labeling. Your extra-label use of Excede™ (ceftiofur crystalline free acid) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a), and resulted in illegal drug residues, in violation of 21 C.F.R. § 530.11(d).

Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs 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).

Prohibited Act (301h) False Guaranty

Our investigation also revealed that on or about October 13, 2011, Mark R. Dolezal, Co-Owner of Dolezal Dairy, signed a Consignor/Livestock Owner’s Certificate to (b)(4) that certifies that none of the livestock delivered to (b)(4) will have an illegal level of drug residues or the producer will inform the (b)(4) of any drugs the livestock have been given. On or about March 22, 2018, you delivered a cow from your farm to (b)(4) which contained violative residues of desfuroylceftiofur. Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. § 331(h). You should take appropriate actions to ensure that this violation does not recur.

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: Attn: Tamara J. Umscheid, Compliance Officer, 8050 Marshall Drive, Suite 205, Lenexa, Kansas, 66214. If you have any questions about this letter, please contact Tamara J. Umscheid, Compliance Officer at (913) 495-5128 or Tamara.Umscheid@fda.hhs.gov.

Sincerely,

/S/

Cheryl A. Bigham

Program Division Director

Office of Human and Animal Foods – Division II West