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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Hulsbosch Dairy Farm 11/16/12

  

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

Public Health Service
Food and Drug Administration
 

Detroit District
300 River Place
Suite 5900
Detroit, Ml 48207
Telephone: 313-393-8100
         FAX: 313-393-8139

WARNING LETTER
(2013-DET-02)

 

November 16, 2012

VIA UPS

Mr. Dominique Hulsbosch
Hulsbosch Dairy Farm
6678 South County Road 700 W
Greensburg, Indiana 47240

Mr. Hulsbosch:

On August 29-30, and September 21, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 6678 South County Road 700 W.  This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) found during our investigation of your operation.  You can find the FD&C Act and its associated regulations on the Internet through links on 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 FD&C 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 FD&C Act, 21 U.S.C. 360(b).  Further, under section 402(a)(4) of the FD&C 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 May 9, 2012 you sold a bob veal calf identified with ear tag number (b)(4) and retain tag number (b)(4) for slaughter as food.  On or about May 9, 2012, (b)(4) 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 ampicillin at a level of 0.38 parts per million (ppm) in the kidney, and flunixin at a level of 0.173 ppm in the liver.  FDA has established a tolerance of 0.01 ppm for residues of ampicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.40 (21 C.F.R. 556.40).  FDA has not established a tolerance for residues of flunixin in the edible tissues of calves intended for slaughter for veal.  The presence of these drugs in the edible tissues from this animal in these amounts causes the food to be adulterated under section 402(a) (2)(C)(ii) of the FD&C 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 FD&C Act, 21 U.S.C. 342(a)(4).

We also found that you adulterated the new animal drugs, Ampicillin Trihydrate, NADA 055-030 and Flunixin Meglumine, ANADA 200-308.  Specifically, our investigation revealed that you did not use ampicillin and flunixin as directed by their approved labeling.  Use of these drugs in this manner is an extralabel use.  See 21 C.F.R. 530.3(a).

The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C 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 ampicillin to an animal identified with ear tag number (b)(4) without observing its intended use or the withdrawal period as stated in the approved labeling.  Your extralabel use of ampicillin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a), and resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Our investigation also found that you administered flunixin to this same animal without following the animal class as stated on the approved labeling.  Your extralabel use of flunixin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a), and resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c).  Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated with the meaning of section 501(a)(5) of the FD&C 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 your overall operation and the food 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 of receiving this letter, 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 Tina M. Pawlowski, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, Michigan 48207.  If you have any questions about this letter, please contact Compliance Officer Pawlowski at (313) 393-8217 or by email at tina.pawlowski@fda.hhs.gov.

Sincerely yours,

/S/

Glenn T. Bass
District Director
Detroit District Office