Nutt Dairy 7/15/11

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 Telephone: 303-236-3000         FAX: 303-236-3100

July 15, 2011

WARNING LETTER

VIA UPS

Mr. Gary Shiflett
Co-Owner
Nutt Dairy
23555 NM Highway 26 NE
Deming, NM 88030

Ref. #:  DEN-11-16-WL

Dear Mr. Shiflett:

On May 10 – 16, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 23555 NM Highway 26, Deming, 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 four 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.

Our investigation revealed that during the period January 13 through March 23, 2011, you consigned for sale as human food, four dairy cows, to b)(4) for sale at auction.  These dairy cows, with ear tags b)(4), were slaughtered by b)(4) and shipped to either b)(4), for human consumption.

United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from these animals identified the presence of illegal residues of Penicillin, Sulfamethazine and Flunixin in the edible tissues of these animals as noted in the table below.

ILLEGAL RESIDUE SUMMARY

Dairy Ear  Tag ID	Delivery     Date	Slaughter   Date	Drug	Tissue	Residue     ppm	Tolerance      ppm
b)(4)	1/13/2011	1/14/2011	Penicillin	Kidney	0.10	0.05 21 CFR 556.510
b)(4)	1/13/2011	1/14/2011	Sulfamethazine	Liver Muscle	33.13   41.90	0.10 21 CFR 556.670
b)(4)	2/24/2011	2/25/2011	Sulfamethazine	Liver Muscle	1.81  0.78	0.10 21 CFR 556.670
b)(4)	2/24/2011	2/25/2011	Sulfamethazine	Liver Muscle	11.35  10.08	0.10 21 CFR 556.670
b)(4)	3/23/2011	3/25/2011	Penicillin	Kidney	0.12	0.05 21 CFR 556.510
b)(4)	3/23/2011	3/25/2011	Flunixin	Liver	0.126	0.125 21 CFR 556.286

     
FDA has established tolerances for residues of  antibiotics in edible tissue of cattle, as codified in Title 21, Code of Federal Regulations, Section 556, (21 CFR 556).  The presence of the drugs in the edible tissues of these animals, as noted in the table, 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 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 adequately review treatment records for medicated animals prior to consignment for sale.  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 acknowledge receipt of your letter dated May 20, 2011 in response to our Form FDA 483, Inspectional Observations, dated May 16, 2011.  Your corrective actions appear to be addressing our concerns.

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/

Mark R. Madson 
Acting District Director