- Animal & Veterinary
- D & E Dairy
- Issuing Office:
- Los Angeles District Office
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
||Los Angeles District
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4415
VIA UNITED PARCEL SERVICE
April 7, 2016
W/L # 27-16
Mr. Daniel J. Nowlin, Owner
D & E Dairy
14189 W. Earley Rd.
Casa Grande, Arizona 85122-8600
Dear Mr. Nowlin:
On December 7, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm ranch located at 14189 W. Earley Rd., Casa Grande, Arizona. 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 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 September 14, 2015, you sold a cow, identified with ear tag 636, to (b)(4). On or about September 15, 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 sulfamethazine at 128.13 ppm in the liver, and at 89.773 ppm in the muscle tissues. FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.670 (21 C.F.R. 556.670). The presence of this drug in tissues from this animal in these amounts 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 drug inventory records and your drug treatment records did not include the route of administration or the dose administered. 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 drug (b)(4). Specifically, our investigation revealed that you did not use (b)(4) as directed by its approved labeling. Use of the 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 (b)(4) to your dairy cow, identified with ear tag 636, without following the withdrawal period as stated in the approved labeling. Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a), and your extralabel use of (b)(4) 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 response should be sent to:
CAPT Daniel Cline
Acting Director, Compliance Branch
Food and Drug Administration
Irvine, CA 92612-2506
If you have questions regarding any issues in this letter, please contact Dr. William Vitale, Compliance Officer at 949-608-2919.
CDR Steven Porter
Los Angeles District
David M. Mazzera, Ph.D.
Chief, Food and Drug Branch
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
Sacramento, CA 95899-7413
Michelle M.. Schack, DVM
Dairy Veterinary Services
500 W. Ray Road, Suite # 5
Chandler, AZ 85225