| 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 Telephone: 303-236-3000FAX: 303-236-3100 |
Department of Health and Human Services
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Joaquin A. Dinis
Mr. Norman D. Dinis
Mr. William M. Dinis
Co-Owners
Empire Dairy, LLC
1473 County Road South
Wiggins, CO 80654-9605
Ref. #: DEN-10-08
Dear Messrs. Dinis:
On January 8 – 14, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1473 County Road South, Wiggins, Colorado. 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 (b)(4), you sold a dairy cow, identified with Empire tag (b)(4) for slaughter as food. On or about (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 12.2 parts per million (ppm) of Desfuroylceftiofur in the kidney (b)(4). FDA has established a tolerance of 0.4 ppm for residues of Desfuroylceftiofur (a marker residue of Ceftiofur) in the kidney tissue of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.113 (21 C.F.R. § 556.113). The presence of this drug in edible tissue from 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)].
In addition, our investigation revealed that on or about (b)(4), you sold a dairy cow, identified with Empire (b)(4) for slaughter as food. On or about (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 1.524 ppm Flunixin in the liver tissue and 0.0558 ppm Flunixin in the muscle tissue (b)(4). FDA has established a tolerance of 0.125 ppm for residues of Flunixin in liver tissue of cattle, and a tolerance of 0.025 ppm Flunixin in muscle tissue of cattle, as codified in 21 C.F.R. § 556.286. The presence of this drug in edible tissue from 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. You failed to review the treatment records for dairy cows, ear tag (b)(4) prior to offering the animals for slaughter for human food to assure that the appropriate withdrawal times had been observed. Food from animals held under such conditions are adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)].
Treatment records were not available for dairy cow (b)(4). In addition, you do not maintain an inventory system for drugs used to medicate your cows that identifies the date and amount administered, and a reconciliation of amount on hand.
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.
We acknowledge receipt of your undated response to our form FDA 483, which we received on February 3, 2010. However, your response is inadequate in that no supporting documentation was provided.
You should notify this office 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 William H. Sherer, Compliance Officer, U.S. Food and Drug Administration, P.O. Box 25087, 6th Avenue and Kipling Street, DFC, Bldg 20, Denver, Colorado, 80225-0087. If you have any questions about this letter, please contact Compliance Officer William S. Sherer at (303) 236-3051 or William.Sherer@fda.hhs.gov.
Sincerely yours,
/S/
H. Thomas Warwick
District Director
Denver District
cc: Ronald C. Nelson, D.V.M.
Denver District Director
USDA/FSIS
PO Box 25387
DFC, Bldg 45
Denver, CO 80225
Tel: 303-236-9800
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