Inspections, Compliance, Enforcement, and Criminal Investigations
SLI Dairy 03-Nov-05
Department of Health and Human Services
Public Health Service
November 3, 2005
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 06-12
Richard Leyendekker, Farm Manager
1860 Harrison Road
Sunnyside, WA 98944
Dear Mr. Leyendekker:
An investigation of your dairy operation located at 2501 SLI Road Sunnyside, Washington, conducted by a representative of the U.S. Food and Drug Administration (FDA) on July 17 and 22, 2005, confirmed that you offered an animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. 342 (a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection also revealed that you caused a new animal drug Maxim 100 to be adulterated within the meaning of Section 501(a)(5) [21 U.S.C. 351(a)(5)] and unsafe under section 512(a) of the Act [21 U.S.C. 360b]. You can find the Act and its associated regulations on the Internet through links on the FDA's Web page at www.fda.gov.
On or about November 15, 2004, you sold a dairy cow, back tag #91T0679 identified on USDA Case # 04-1342-WA and further identified on USDA-FSIS lab report #431312, for slaughter as food to [redacted]. On or about November 16, 2005, this animal was slaughtered at [redacted]. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of oxytetracycline in the kidney at 27.76 parts per million (ppm). A tolerance of 12 ppm in the kidney has been established for a residue of oxytetracycline as codified in Title 21, Code of Federal Regulations (CFR), Part 556.500 (21 C.F.R. 556.500). The presence of this drug at the reported levels in the edible tissues of this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [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 treatment records for your animals that identify the drug used, the dates of treatment, the dosage given, the route of administration, and drug withdrawal time. 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)].
In addition, you adulterated the drug Maxim-100 (Oxytetracycline Hydrochloride Injection Antibiotic) within the meaning of section 501(a)(5) [21 U.S.C. 351 (a)(5)] of the Act when you failed to use the drug in conformance with its approved labeling. "Extralabel use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) and 512(a)(5) of the Act and 21 C.F.R. Part 530. Our investigation found that your extralabel use of Maxim-100 failed to comply with these requirements. For example, you administer the Maxim-100 as an injection into a quarter of the cow's udder to treat mastitis, or in the neck veins for infections. The labeling calls for slow intravenous administration of the drug, and has a warning statement stating that it is not to be used in lactating dairy cattle. Also, you administer 40 ml of the Maxim-200 to cows, even though the approved labeling directs a maximum of 30 ml per cow. You used this .drug in an extralabel manner without the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.1(a). Furthermore, your extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d).
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 above violations and to establish procedures whereby such 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, 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 Lisa M. Elrand, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions about this letter, please contact Compliance Officer Elrand at 425-483-4913; fax is 425-483-4760; or email at email@example.com.
Charles M. Breen