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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 22, 2014
Harold Griffith, Co-Owner / President
Steven F. Griffith, Co-Owner / Secretary
Matthew Padilla, Co-Owner / Worker
16120 County Road 24
Fort Morgan, Colorado 80701
Ref. #: DEN-14-06-WL
On February 24-26, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy and heifer raising operation located at 16120 County Road 24, Fort Morgan, Colorado. 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 found that on or about October 17, 2013, you sold a dairy cow identified with ear tag (b)(4) for slaughter as food. On or about October 17, 2013, (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 gentamicin in the kidney tissue. FDA has not established a tolerance for residues of gentamicin in edible tissue of cattle. The presence of this drug 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 maintain treatment records for animals that you medicate. 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 new animal drug (b)(4). Specifically, our investigation revealed that you did not use this drug as directed by its approved labeling or by the directions of the prescribing veterinarian. Use of this drug in this manner is an extralabel use. See Title 21, Code of Federal Regulations (C.F.R.), section 530.3(a), 21 C.F.R. 530.3(a). A copy of 21 C.F.R. Part 530 is attached for your reference.
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 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 gentamicin to a dairy cow identified with ear tag (b)(4) without following the animal species as stated in the approved labeling or the veterinarian prescription labeling. Your extralabel use of gentamicin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of gentamicin resulted in illegal drug residues, in violation of 21 CFR 530.11(c). Because your use of this drug was not in conformance with its approved labeling or the veterinarian’s prescription label, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a)(4), 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 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.
Our investigation also revealed that on October 17, 2013, Mr. Stephen F. Griffith provided to (b)(4), a Drug Affidavit that states that the animals presented to (b)(4) for slaughter are clear of all residual drugs. On or about October 17, 2013, you delivered a dairy cow identified with ear tag (b)(4), which contained violative residues of gentamicin, to (b)(4). Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. § 331(h). You should take appropriate actions to ensure that this violation does not recur.
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 U.S. Food and Drug Administration, P.O. Box 25087, Denver, Colorado 80225-0087, Attention: Thomas R. Berry, PharmD, Compliance Officer. If you have any questions about this letter, please contact Dr. Berry at (303) 236-3028.
LaTonya M. Mitchell
cc: Anna Gallegos
Denver District Manager
PO Box 25387
1 Denver Federal Center
DFC, Building 45 S3
Denver, Colorado 80225
John Salazar, Commissioner
Colorado Department of Agriculture
700 Kipling Street, Suite 4000
Lakewood, Colorado 80215