Inspections, Compliance, Enforcement, and Criminal Investigations
Rock Creek Dairy #3 7/1/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
VIA FED EX
In reply refer to Warning Letter SEA 09-21
Luis Bettencourt., Owner
Sharon Bettencourt, Owner
dba Bettencourt, LLC
dba Rock Creek Dairy #3
2930 South 2300 East
Wendell, Idaho 83355
Dear Mr. and Mrs. Bettencourt:
On February 18 and 23, 2009, the U.S. Food and Drug Administration (FDA) conducted an inspection of your Rock Creek Dairy #3 operation located at 2175 East 3500 North, Filer, Idaho. 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 for sale an animal for slaughter as food that was 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.
Specifically, our investigation revealed that on or about November 4, 2008, you sold a dairy cow for slaughter as food to (b)(4). The cow was identified with back tag number (b)(4) by (b)(4). On November 4, 2008 (b)(4) sold the cow with back tag number (b)(4) to (b)(4) who slaughtered the 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 sulfadimethoxine at 0.62 parts per million (ppm) in the liver, and 0.55 ppm in the muscle. 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 C.F.R. 556.640). The presence of this drug in edible 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 Act, 21 U.S.C. § 342(a)(2)(C)(ii).
We also found that you adulterated the new animal drug sulfadimethoxine. Specifically,our investigation revealed you did not use sulfadimethoxine as directed by its approved labeling. Use of these drugs in this manner is an extralabel use as codified in 21 C.F.R. 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 implementing regulations at 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 sulfadimethoxine (Albon) to a dairy cow with ear tag number (b)(4) without following the dosing instructions for use as stated in the approved labeling. Sulfadimethoxine is prohibited for extralabel use in lactating dairy cows by 21 C.F.R. 530.41(a)(9). 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 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 food you distribute is in compliance with the law.
Our investigation also revealed that you use DI-METHOX Sulfadimethoxine Injection 40% in a manner that is not in accordance with its approved labeling. Please be aware that extralabel use, i.e., the actual intended use of a sulfonamide drug in a manner that is not in accordance with the approved labeling is prohibited under 21 CFR 530.41(a)(9) for lactating cows.
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 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 425-483-4760; email email@example.com.
Charles M. Breen
cc: U.S. Dept. of Agriculture
Food Safety and Inspection Service
Denver Federal Center
P.O. Box 25387, Building 45
Denver, CO 80225