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  5. Windmill Dairy - 03/24/2016
  1. Warning Letters

WARNING LETTER

Windmill Dairy

Product:
Animal & Veterinary

Recipient:
Windmill Dairy


United States

Issuing Office:
Los Angeles District Office

United States


   

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

Public Health Service
Food and Drug Administration
  Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4415 

 

WARNING LETTER
 
 
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
 
March 24, 2016
                       WL # 25-16
Mr. Arie De Jong, Co-Owner
Windmill Dairy
3179 W. Cottonwood Road, Box 8
Casa Grande, Arizona 85194-7372
 
Dear Mr. De Jong:
 
On August 19 and December 10, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation, Windmill Dairy, located at 3179 W. Cottonwood Road, Box 8, Casa Grande, Arizona 85194-7372. 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 FDA’s web page at www.fda.gov.
 
We found that you offered for sale two animals for slaughter as food that were 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 23, 2015, you sold a dairy cow identified with back tag (b)(4), for slaughter as food. On or about March 25, 2015, (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 0.239 parts per million (ppm) of penicillin in the kidney tissue. In addition, our investigation also revealed that on or about April 06, 2015, you sold a dairy cow identified with back tag (b)(4), for slaughter as food. On or about April 09, 2015, (b)(4). United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 0.082 ppm of penicillin in the kidney tissue. FDA has established a tolerance of 0.05 ppm for residues of penicillin in uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (CFR), Section 556.510(a) (21 C.F.R. 556.510(a)). 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. 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 FD&C Act, 21 U.S.C. 342(a)(4).
 
We also found that you adulterated the new animal drug Penicillin Injectable aqueous suspension (penicillin G procaine injectable suspension, NADA # (b)(4). Specifically, our investigation revealed that you did not use this drug as directed by its approved labeling and/or by a veterinarian’s prescription. 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. 
 
Our investigation found that you administered Penicillin Injectable aqueous suspension (penicillin G procaine injectable suspension, NADA #(b)(4) to a dairy cow identified with back tag (b)(4) and to a dairy cow identified with back tag (b)(4), without following the dosing instructions (injection site limitations) stated in the approved drug labeling. Your extralabel use of the Penicillin Injectable aqueous suspension was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a), and your extralabel use of the Penicillin Injectable aqueous suspension resulted in an illegal drug residue, 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).
 
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 CAPT Daniel Cline, Acting District Director, Compliance Branch, U.S. Food and Drug Administration, 19701 Fairchild, Irvine, California 92612-2506. If you have any questions about this letter, please contact Compliance Officer Marco S. Esteves at (949) 608-4439 or by e-mail at marco.esteves@fda.hhs.gov.
 
Sincerely yours,
/S/ 
LCDR Steven Porter, Acting Director
Los Angeles District
 
 
Cc:      
Mrs. Nina De Jong, Co-Owner
Windmill Dairy
3179 W. Cottonwood Road, Box 8
Casa Grande, Arizona 85194-7372
 
Mr. Travis Brown, General Manager
Windmill Dairy
3179 W. Cottonwood Rd. Box 8
Casa Grande, AZ 85194-7372
 
Mrs. Marina Brown, Trustee
Windmill Dairy
3179 W. Cottonwood Rd. Box 8
Casa Grande, AZ 85194-7372
 
Mr. Benito Castellanos, Windmill Dairy Manager
Windmill Dairy
3179 W. Cottonwood Road, Box 8
Casa Grande, Arizona 85194-7372