Marcellina Dairy 12/26/12
| 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: 303-236-3000
FAX: 303-236-3100
|
Department of Health and Human Services
December 26, 2012
WARNING LETTER
VIA UPS
Mr. Roswell L. Checketts, Owner
Marcellina Dairy, LLC
21506 County Road 43
LaSalle, CO 80645
Ref. #: DEN-13-5-WL
Dear Mr. Checketts:
During the period November 26 – 30, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 21506 County Road 43, LaSalle, 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 the FDA’s web page at www.fda.gov.
We found that you offered animals for sale 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 August 7, 2012, you delivered a dairy cow you owned, identified with ear tag (b)(4) for slaughter as food. The animal was slaughtered on or about August 8, 2012. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 2.105 parts per million (ppm) Sulfamethazine in the liver tissue.
FDA has established a tolerance of 0.1 ppm for residues of Sulfamethazine in the uncooked edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.670, (21 CFR 556.670). The presence of this drug in the edible tissue of 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 maintain and review complete and accurate treatment records for medicated animals that are sold for food. 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)].
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 foods 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.
You should notify this office in writing within fifteen (15) working days of receiving this letter of any additional steps you have taken to bring your firm into compliance with the law. 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 timeframe within which the corrections will be completed. Please include copies of any available documentation, such as written procedures, hospital records, inventory records, and training records demonstrating that corrections have been made.
Your written response should be sent to: U.S. Food and Drug Administration, P.O. Box 25087, (6th Avenue and Kipling Street, DFC, Bldg 20), Denver, CO 80225-0087, Attention: Howard E. Manresa, Director of Compliance. If you have any questions about this letter, please contact Mr. Manresa at (303) 236-3019, or by email athoward.manresa@fda.hhs.gov
Sincerely,
/S/
LaTonya M. Mitchell
Denver District Director
cc:
Ronald C. Nelson, D.V.M.
Denver District Manager
USDA/FSIS
PO Box 25387
DFC, Bldg 45
Denver, CO 80225
Mr. John Salazar, Commissioner
Colorado Department of Agriculture
700 Kipling St., Suite 4000
Lakewood, CO 80215