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WARNING LETTER

Roorda Dairy MARCS-CMS 556590 —

Product:
Animal & Veterinary

Recipient:
Recipient Name
Mr. Larry Roorda, Mr. Scott Roorda, Mr. Lance Roorda
Roorda Dairy

5128 460th Street

Paullina, IA 51046-7700
United States

Issuing Office:
Kansas City District Office

United States


 

   

Black HHS-Blue FDA Logo

 

 

 
Office of Human and Animal Food
West Division II
8050 Marshall Drive - Suite 205
Lenexa, Kansas 66214-1524
913-495-5100 

 

WARNING LETTER
 
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
July 9, 2018
 
Mr. Larry Roorda, Co-Owner
Mr. Scott Roorda, Co-Owner
Mr. Lance Roorda, Co-Owner
Roorda Dairy, LLC
5128 460th Street
Paullina, Iowa 51046-7700
 
Reference: CMS Case #556590
 
 
Dear Messrs. Larry Roorda, Scott Roorda, and Lance Roorda,
 
On April 17 and April 23, 2018, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 5128 460th St., Paullina, Iowa. 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 the FDA’s web page at www.fda.gov.
 
Our investigation 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.
 
Specifically, our investigation revealed that on or about January 2, 2018, you sold a cow identified with ear tag (b)(4) for slaughter as food. On or about January 3, 2018, (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 tetracycline at 65.05 parts per million (ppm) in the kidney tissue and tetracycline at 6.73 parts per million (ppm) in the muscle tissue. 
 
FDA has established a tolerance of 12 ppm for residues of tetracycline in the kidney tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), section 556.500(b)(3) (21 C.F.R. § 556.500(b)(3)). FDA has established a tolerance of 2 ppm for residues of tetracycline in the muscle tissues of cattle as codified in 21 C.F.R. § 556.500(b)(1). The presence of this drug in edible tissue of this animal in amounts above the tolerance 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 adulterated the new animal drug Vetrimycin™ 100 (oxytetracycline hydrochloride, ANADA 200-452). Specifically, our investigation revealed that you did not use Vetrimycin™ 100 as directed by its approved labeling. You stated in your affidavit that the animal identified with ear tag (b)(4) was treated with Vetrimycin™ 100 as an intrauterine infusion, whereas the drug is labeled for intravenous use only. 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.
 
In a signed affidavit from Mr. Larry Roorda, he stated the decision to use oxytetracycline in an off-label manner as an intrauterine infusion was based on advice that your herdsman had obtained from a colleague in the dairy industry. There is no evidence to suggest that the extralabel use was authorized by a veterinarian. Therefore, your extralabel use of Vetrimycin™ 100 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 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).
 
Our investigation also revealed that on or about July 11, 2013, Mr. Larry Roorda provided to (b)(4), a Livestock Owner Certificate that states that the animals presented for slaughter do not have an illegal level of drug residues. On or about January 2, 2018, you delivered a dairy cow identified with ear tag #(b)(4), which contained violative residues of tetracycline, to (b)(4).   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 Andrew A. Hoopes, Compliance Officer, U.S. Food and Drug Administration, 8050 Marshall Dr. Suite 205, Lenexa KS, 66214. If you have any questions about this letter, please contact Compliance Officer Hoopes at515-244-0480 ext. 1002, andrew.hoopes@fda.hhs.gov.
 
 
Sincerely yours,
/S/ 
Cheryl Bigham
Program Division Director
Office of Human and Animal Foods – Division II West
 
  
 
Cc:
 
(b)(4)
 
(b)(4)