| 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
June 15, 2011
WARNING LETTER
VIA UPS
Mr. Noe N.L. Landaverde
Co-Owner
N.S. Landaverde Cattle Ranch
61 East Orchard Park Road
Dexter, NM 88230
Ref. #: DEN-11-14-WL
Dear Mr. Landaverde:
On May 10 – 11, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 61 Orchard Park Road, Dexter, New Mexico. 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 an animal for sale 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]. 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 January 31, 2010, you sold a bob veal calf for slaughter as food to (b)(4) identified the calf with house (b)(4) and slaughtered it on or about February 1, 2010. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 20.73 parts per million (ppm) (b)(4) in the kidney tissue.
FDA has established a tolerance of 7.2 ppm for residues of (b)(4) in the kidney tissue of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.430, (21 C.F.R. 556.430). The presence of this drug in the edible tissues 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. In addition, you failed to maintain and review complete treatment records for medicated animals. 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 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, Denver, CO 80225-0087. If you have any questions about this letter, please contact Mr. Sherer at (303) 236-3051, or by email at william.sherer@fda.hhs.gov
Sincerely,
/S/
Howard E. Manresa
Acting District Director
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