Desert Star Dairy 4/13/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
April 13, 2012
Mr. David McDermid, Owner
Desert Star Dairy, LLC
12 Roosevelt Rd. A
Texico, NM 88135
Ref. #: DEN-12-13-WL
Dear Mr. Dermid:
On March 5 – 9, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 12 Roosevelt Road A, Texico, New Mexico. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act, and its associated regulations, on the Internet through links on the FDA’s web page at www.fda.gov
We found that you offered animals for sale for slaughter as food that were 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 November 7, 2011, you sold a dairy cow, identified with ear tag (b)(4), for slaughter as food, (b)(4). The dairy cow was purchased by (b)(4) and slaughtered on or about November 9, 2011. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 0.12 parts per million (ppm) Sulfadimethoxine in the liver tissue.
FDA has established a tolerance of 0.1 ppm for residues of Sulfadimethoxine in the uncooked edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.640, (21 CFR 556.640). The presence of this drug in the edible tissue of 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 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. In addition, you failed to maintain and review complete treatment records for medicated animals which are sold for food. 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 the new animal drug Sulfadimethoxine. Specifically, our investigation revealed that you did not use (b)(4) (Sulfadimethoxine) (b)(4) as directed by its approved labeling. Use of this drug in this manner is an extralabel use, 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.
Our investigation found that you administered Sulfadimethoxine to dairy cow, ear tag # (b)(4), without following the dose and duration of treatment as stated in the approved labeling. Your extralabel use of Sulfadimethoxine was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a), and your extralabel use of Sulfadimethoxine resulted in an illegal drug residue, in violation of 21 CFR 530.11(d).
Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 CFR Part 530, you caused the drug 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 foods 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.
We acknowledge receipt of Mr. Jeffrey Poland’s undated letter that we received on March 23, 2012, responding to our Inspectional Observations, Form FDA 483 issued on March 9, 2012. Your firm’s response is inadequate in that it did not include documentation of the corrective actions you have taken.
You should notify this office in writing within fifteen (15) working days of receiving this letter of any additional steps you have taken to bring your firm into compliance with the law. 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, state the reason for the delay and the timeframe within which the corrections will be completed. Please include copies of any available documentation, such as written procedures, hospital records and inventory records, demonstrating that corrections have been made.
Your written response should be sent to: U.S. Food and Drug Administration, P.O. Box 25087, (6th
Avenue and Kipling Street, DFC, Bldg 20), Denver, CO 80225-0087, Attention: William H. Sherer, Compliance Officer. If you have any questions about this letter, please contact Mr. Sherer at (303) 236-3051, or by email at email@example.com
LaTonya M. Mitchell
Denver District Director
Ronald C. Nelson, D.V.M.
Denver District Manager
PO Box 25387
DFC, Bldg 45
Denver, CO 80225
I. Miley Gonzalez, Ph.D.
New Mexico Department of Agriculture
New Mexico State University
P.O. Box 300005, MSC 3189
Las Cruces, NM 88003-8005