Inspections, Compliance, Enforcement, and Criminal Investigations
Crestview Calves, Inc.
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
February 16, 2010
RETURN RECEIPT REQUESTED
/or/ Federal Express
In reply refer to Warning Letter SEA 10-13
Cody G. Morgan; Owner / President
Crestview Calves, Inc.
756 South 2800 East
Hazelton, Idaho 83335-5280
Dear Mr. Morgan:
On November 3 and 5, 2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your calf raising operation located at 756 South 2800 East, Hazelton, Idaho 83335-5280. 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 FDA's web page at www.fda.gov.
We found that you offered for sale animals 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 or about August 14, 2009, you sold a calf, identified with back tag (b)(4), for slaughter as food. On or about August 14, 2009, (b)(4) slaughtered this animal. In addition, our investigation revealed that on or about August 26, 2009, you sold a calf, identified with back tag (b)(4) for slaughter as food. On or about August 26, 2009, this animal was also slaughtered at (b)(4). United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from these animals identified the presence of gentamicin sulfate in the kidney tissues. FDA has not established a tolerance for residues of gentamicin sulfate in the edible tissues of cattle. The presence of this drug in edible tissue from these animals 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 treatment records for the animals identified with back tags (b)(4) and (b)(4) 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 gentamicin sulfate. Specifically, our investigation revealed that you did not use gentamicin sulfate as directed by the veterinarian's prescription labeling nor as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See Title 21, Code of Federal Regulations, Section 530.3(a) (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 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 gentamicin sulfate to two calves, back tags (b)(4) and (b)(4) without following the dose and withdrawal period as stated in the
veterinarian's prescription labeling nor as directed by its approved labeling. Your extralabel use of gentamicin sulfate resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11 (c). 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.
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 Scott A. Nabe, 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 Nabe at (425) 483-4753.
Charles M. Breen