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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Providence Dairy, LLC 3/17/10

  

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, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139

WARNING LETTER
2010-DT-09

 

March 17, 2010

 

VIA FEDERAL EXPRESS

 

Mr. Arie Jan de Jong, Owner
Providence Dairy, LLC
8801 East County Road 800 North
Twelve Mile, Indiana 46988-9314

Dear Mr. Jan de Jong:

On September 10 and 28, 2009 the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 8801 East County Road 800 North, Twelve Mile, Indiana 46988, 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 FDA's web page at www.fda.gov.

We found that you offered for sale animals 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. 360(b). 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 the dates of May 26, 2009, June 1, 2009,  June 18, 2009, June, 25, 2009, and July 23, 2009, you sold cows identified with ear tag numbers (b)(4) respectively, for slaughter as food. On or about May 27, 2009, June 2, 2009, June 23, 2009, June, 26, 2009, and July 24, 2009, (b)(4) slaughtered the cows identified with ear tag numbers" (b)(4) and (b)(4)  respectively. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from each of these animals identified the presence of the following drugs in parts per million (ppm):

Cow Ear Tag

 

Cow House TagSlaughter Date

Drug(s)

 

Tissue AnalyzedLevel Found (ppm)
(b)(4)(b)(4)7/24/2009PenicillinKidney0.11
(b)(4)(b)(4)6/02/2009PenicillinKidney0.12
(b)(4)(b)(4) SulfadimethoxineLiver0.50
(b)(4)(b)(4)6/26/2009NeomycinKidney21.47
(b)(4)(b)(4) SulfadimethoxineLiver0.124
(b)(4)(b)(4)5/27/2009NeomycinKidney12.44
(b)(4)(b)(4)6/23/2009FlunixinLiver0.2428

 

FDA has established a tolerance for each of these new animal drugs as follows: 0.05 ppm for residues of penicillin in uncooked edible tissue of cattle as codified in Title 21, Code of Federal Regulations, Section 556.510(a) (21 C.F.R. § 556.510(a)); 0.125 ppm for residues of flunixin in liver tissue of cattle as codified in 21 C.F.R. § 556.286(b)(1)(i); 0.1 ppm for residues of sulfadimethoxine in the uncooked edible tissue of cattle as codified in 21 C.F.R. § 556.640(b)(1); and, 7.2 ppm for residues of neomycin in kidney tissue of cattle as codified in 21 C.F.R. § 556.430(b)(1). The presence of these drugs in edible tissue from these animals in these amounts cause the food to be adulterated under 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 drugs penicillin, flunixin, neomycin and sulfadimethoxine. Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs in this manner is an extralabel use in violation of 21 C.F.R. § 530.3(a).

The extra-label use of approved new animal or human drugs in animals is allowed under the Act only if the extra-label use complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. 360(b)(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 penicillin to the animals with ear tag numbers (b)(4) and (b)(4) without following the dose as stated in the approved labeling. Your extralabel uses of penicillin were not under the supervision of a license veterinarian, in violation of 21 C.F.R. § 530.11(a) and your extralabel uses of penicillin resulted in illegal drug residues, in violation of 21 C.F.R. § 530.11(d). Our investigation found that you administered flunixin to the animal with ear tag number and the animal with ear tag number (b)(4) without following the route of administration as stated in the approved labeling. Your extralabel uses of flunixin were not under the supervision of a license veterinarian, in violation of 21 C.F.R. § 530.11(a) and your extralabel uses of flunixin resulted in illegal drug residues, in violation of 21 C.F.R. § 530.11(d). Our investigation found that you administered neomycin to the animals with ear tag numbers (b)(4) without following the animal class as stated in the approved labeling. Your extralabel use of neomycin was not under the supervision of a license veterinarian, in violation of 21 C.F.R. § 530.11 (a) and your extralabel use of neomycin resulted in illegal drug residues, in violation of 21 C.F.R. § 530.11(d). Our investigation found that you administered sulfadimethoxine to the animal with ear tag number 12005 without following the indication as stated in the approved labeling. Sulfadimethoxine is prohibited for extralabel use in lactating dairy cattle 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 these drugs were 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 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).

Our investigation also revealed that on or about March 18, 2003, you provided (b)(4) with a signed "Livestock Owner Certificate" stating that none of the livestock supplied to (b)(4) will have an illegal level of drug residues. This signed agreement covered the cows identified with ear tag numbers (b)(4) which were found to contain violative residues of penicillin, neomycin/sulfadimethoxine, flunixin, penicillin/sulfadimethoxine, and neomycin, respectively. Providing such a false guaranty is prohibited by section 301(h) of the Act, 21 U.S.C. 331(h). You should take appropriate actions to ensure that this violation does not recur.

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 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, Ph.D., Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, MI 48207. If you have any questions about this letter, please contact Compliance Officer Pawlowski at (313) 393-8127 or by email at tina.pawlowski@fda.hhs.gov.

Sincerely,

/a/

Joann M. Givens
District Director
Detroit District Office