| 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 |
Department of Health and Human Services
WARNING LETTER
(2010-DT-19)
September 29, 2010
VIA UPS
Mr. Joel Van Ravenswaay, Partner
Newberry Farms, LLC
579 Box Street
Demotte, Indiana 46310
Mr. Van Ravenswaay:
On July 13 and 15, 2010 the U,S, Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 4618 North 200 West, Rensselaer, Indiana 47978. 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 February 4, 2010, you sold a cow identified with ear tag number (b)(4) for slaughter as food. On or about February 5, 2010, (b)(4) slaughtered a cow identified with ear tag number (b)(4) and House Tag (b)(4) United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of kidney tissue collected from this animal identified the presence of penicillin at a level of 0.1 parts per million (ppm), FDA has established a tolerance of 0.05 ppm, for penicillin, in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Section 556.510(a) (21 C.F.R. § 556.510(a)), The presence of this drug in the edible tissue of this animal, in this amount, causes 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)].
Our investigation also revealed that on or about April 23, 2009, 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 cow identified with ear tag number (b)(4) which was found to contain a violative residue of penicillin. 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. Please include copies of any available documentation demonstrating that corrections have been made. If corrective actions 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.
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 yours,
/S/
Joann M. Givens
Detroit District Director
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