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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Hart Dairy II 11-Aug-08

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128


August 11, 2008

2008-DAL-WL-20

Certified Mail
Return Receipt Requested

WARNING LETTER

Laurens Schilderink, Owner
Ilona Schilderink, Owner
Hart Dairy II
1970 County Road 622
Hart, Texas 79043

Dear Mr. and Mrs. Schilderink:

On June 13-17, 2008, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 2101 FM 1172 Friona, Texas 79035. 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 for sale an animal 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 March 27, 2008, you sold a dairy cow identified with farm tag # [redacted] for slaughter as food. On or about March 28, 2008, [redacted] slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of sulfadimethoxine in the muscle at 0.41 parts per million (ppm) and in the liver at 0.11 ppm. FDA has established a tolerance of 0.1 ppm sulfadimethoxine in the uncooked edible tissues of cattle for residues as codified in Title 21, Code of Federal Regulations (C.F.R,), 556.640(b)(1) (21 C.F.R. 556.640(b)(1)). The presence of this drug in edible tissues from this animal in these amounts 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 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).

We also found that you adulterated the new animal drug sulfadimethoxine [redacted] brand [redacted]. Specifically, our investigation revealed that you did not use sulfadimethoxine as directed by its approved labeling. Use of this drug in this manner is an extralabel use. 21 C.F.R. 530.3(a).

The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.

Our investigation found that you administered sulfadimethoxine to a dairy cow without following the route of administration, withdrawal period, and indication for use as stated in the approved labeling. Sulfadimethoxine is prohibited for extralabel use in lactating dairy catte by 21 C.F.R. 530.41(a)(9) and your extralabel use of sulfadimethoxine resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the Act, 21 U.S.C. § 351(a)(5).

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 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 Compliance Officer Sherrie L. Krolczyk, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about this letter, please contact the Compliance Officer, Sherrie L. Krolczyk at the above address.


Sincerely,

/S/

Reynaldo R. Rodriguez, Jr
Dallas District Director

RRR/slk

cc: Dean T. Yorton, General Manager
Hart Dairy II
1970 County Road 622
Hart, Texas 79043

FSIS District Office 40
Attn: District Manager
1100 Commerce Street, Room 516
Dallas, Texas 75242-0598