Inspections, Compliance, Enforcement, and Criminal Investigations
J & S Dairy Farm Inc. 20-Jun-08
Department of Health and Human Services
Public Health Service
June 20, 2008
RETURN RECEIPT REQUESTED
Mr. Floris DeBruin, Co-Owner/Manager
J & S Dairy Farm Inc.
1230 CR 1038
Muleshoe, Texas 79347-6649
Dear Mr. DeBruin:
An inspection of your dairy operation located at 1230 CR 1038, Muleshoe, Texas, conducted by a representative of the U.S. Food and Drug Administration (FDA) on March 18 and 19, 2008, confirmed that you offered an animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii), and 402(a)(4), of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(2)(C)(ii) and 21 U.S.C.,§ 342(a)(4)]. You can find the Act and its associated regulations on the internet through links on the FDA's web page at www.fda.gov.
On or about December 5, 2007, J & S :Dairy sold a dairy cow identified with the Back Tag to (b)(4) to (b)(4)(cattle dealer). On or about December 5, 2007; this animal was subsequently hauled to and slaughtered as food 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 penicillin at 0.10 parts per million (ppm) in the kidney tissue. A tolerance of 0.05 ppm has been established for residues of penicillin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations, section 556.510 (21 C.F.R. § 556.510). The presence of this drug in this amount in edible tissue from this animal 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 inspection 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 your firm have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, your firm failed to maintain complete treatment records. 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)].
At the completion of the inspection a Form FDA 483, Inspectional Observations, describing deficiencies in your operations was issued and discussed with you. A copy of that document is attached for your information.
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 that 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 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 competed. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to James R. Lahar, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204-3128. If you have, any questions about this letter, please contact Mr. Lahar at 214 253-5219.
Reynaldo R. Rodriguez, Jr.
Enclosure: Form FDA-483, Inspectional Observations dated 3/19/08
cc: Joel D. Shearer, Co-Owner
J & S Dairy Farm Inc.
544 CR 1058
Muleshoe, Texas 79347
Stanley R. Jones, Co-Owner
J & S Dairy Farm Inc.
42547 US 70
Portales, New Mexico 88130
Howard "Butch" Johnson, DVM
Texas Department of State Health Services
Environmental and Consumer Safety Section
Meat Safety Assurance Unit
1100 West 49th Street
Austin, Texas 78756