Northside Farms LLC

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Dallas District 4040 North Central Expressway Dallas, Texas 75204·3128

 

June 9, 2011

 

REF: 2011-DAL-WL-12

 

 

WARNING LETTER

 

 

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

 

Mr. Donald A. De Jong, Owner and Manager

Northside Farms, LLC

P.O. Box 659

Hartley, Texas 79044

 

Dear Mr. De Jong:

 

On March 21, 2011 through March 24, 2011, a representative of the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 4550 County Road 1, Dalhart, Texas. 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 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.

 

On or about August 31, 2010, you consigned a dairy cow, identified with ear tag number (b)(4), for slaughter as food at (b)(4). On or about August 31, 2010, this animal was slaughtered at (b)(4). United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 1.12 ppm Flunixin in the liver (FSIS sample number 511230). A tolerance of 0.125 ppm has been established for residues of Flunixin in the liver tissue of cattle, as codified in Title 21, Code of Federal Regulations, Part 556.286 (21 CFR 556.286). The presence of this drug in edible tissue from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [(21 U.S.C. § 342(a)(2)(C)(ii)].

 

Additionally, on or about September 3, 2010, you consigned a dairy cow, identified with ear tag number (b)(4), for slaughter as food at (b)(4). On or about September 3, 2010, this animal was slaughtered at (b)(4). USDA/FSIS analysis of tissue samples collected from that animal identified the presence of 0.315 ppm Flunixin in the liver (FSIS sample number 511232). A tolerance of 0.125 ppm has been established for residues of Flunixin in the liver tissue of cattle, as codified in Title 21, Code of Federal Regulations, Part 556.286 (21 CFR 556.286). The presence of this drug in edible tissue from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [(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. You lack 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. For example, you failed to maintain complete treatment records, in that your records for the cows with ear tags ending in (b)(4) and (b)(4) failed to include the drug(s) used, date they were administered, dosage, route of administration, person administering the treatment, or the withdrawal time for milk and meat. 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 your letter dated March 31, 2011, in which you responded to the Form FDA 483 Inspectional Observations that was issued to you on March 24, 2011. However, because you did not provide any evidence to show that you have implemented the corrective actions promised in your letter, the letter is not adequate to provide corrective actions to the violations.

 

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.

 

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 Seri L. Essary, Compliance Officer, U.S. Food and Drug Administration, 4040 N. Central Expressway, Dallas, Texas, 75204. If you have any questions about this letter, please contact Seri Essary at (214)253-5335 or Shari Shambaugh, Director Compliance Branch at (214)253-5215.

 

 

Sincerely,

/S/

Reynaldo R. Rodriguez, Jr.

Dallas District Director

-