| 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 ServicesWARNING LETTER
(2011-DET-11)
July 6, 2011
VIA UPS
Bastiaan de Jong, President
De Jong Dairy, Inc.
15565 Lockshore Road
Hickory Corners, MI 49060-9716
Dear Mr. de Jong:
On May 18 and 24, 2011 the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 15565 Lockshore Road, Hickory Corners, Michigan 49060. 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 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. § 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 September 1, 2010 you sold a cow identified with ear tag number (b)(4) for slaughter as food. On or about September 1, 2010, (b)(4) slaughtered the cow identified with ear tag number (b)(4). United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of liver tissue collected from this animal identified the presence of Sulfamethazine at a level of 0.117 parts per million (ppm). FDA has established a tolerance of 0.1 ppm for residues of Sulfamethazine in the liver tissue of cattle as codified in Title 21, Code of Federal Regulations, Section 556.670 [21 C.F.R. 556.670]. 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)].
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.
Our investigation also revealed that on or about December 13, 2006, 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 covers the cow identified with ear tag number (b)(4) which was found to contain violative residues of Sulfamethazine. 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.
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, MI 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/
Kathleen M. Sinninger
Acting District Director
Detroit District Office
No comments:
Post a Comment