Inspections, Compliance, Enforcement, and Criminal Investigations
Chesterfield Dairy 6/25/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Cincinnati District Office|
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771
June 25, 2009
VIA FEDERAL EXPRESS
Johannes Vande Kolk, Co-Owner
15710 County Road 14
Lyons, Ohio 43533
Dear Mr. Vande Kolk:
On March 3, 4, and 25, 2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 15710 County Road 14, Lyons, Ohio 43533. 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. § 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 September 15, 2008, you consigned five cows, one of which was a dairy cow with back tag (b) (4) for slaughter as food. On or about September 17, 2008, (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 0.158 ppm of flunixin in the liver. FDA has established a tolerance of 0.125 ppm for residues of flunixin in the liver of cattle as codified in Title 21, Code of Federal Regulations, Section 556.286 (21 C.F.R. 556.286).The presence of this drug in edible tissue from this animal in this amount 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).
The investigation also revealed that you provided a false guaranty, a prohibited act under section 301(h) of the Act, 21 U.S.C. § 331(h). On or about September 15, 2008, you provided (b) (4) with a signed livestock owner's certification stating that none of the livestock described on the invoice, including the cow identified with backtag (b) (4) which was found to have a violative flunixin residue, was adulterated with illegal levels of drug residue within the meaning of the Act. Pursuant to section 301(h) of the Act, 21 § U.S.C. 331(h), providing such a false guaranty is a prohibited act.
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.
The investigation also found that you routinely administer (b)(4) (Flunixin Meglumine) Injectable Solution, (b)(4) to dairy cows without following the dosage as stated in the approved labeling. Specifically, you stated that you routinely administer 10-15 cc of (b)(4) to cows and that the temperature of the animal determines the dosage you administer. Use of this drug in this manner is an extralabel use. 21 C.F.R. 530.3(a). Your extralabel use of (b)(4) (Flunixin Megluruine) Injectable Solution, (b)(4) is not under the supervision of a licensed veterinarian, as required by 21 C.F.R. 530.11 (a). This practice may result in giving the wrong dose to an animal, which could result in an illegal drug residue.
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 Gina M. Brackett, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Compliance Officer Gina Brackett at (513) 679-2700 Ext. 167.
Teresa C. Thompson
cc: Dr. Tony Forshey, Acting Chief
Ohio Department of Agriculture
8995 East Main Street
Reynoldsburg, Ohio 43068-3399
Dr. Isabel Arrington, Director TA/C
United States Department of Agriculture (USDA)
Food Safety and Inspection Service (FSIS)
Landmark Center, Suite 300
1299 Farnam Street
Omaha, Nebraska 68102
Gregory J. Crosley, D.V.M.
Countryside Veterinary Service, P.C.
14247 East Chicago Road
Somerset, Michigan 49281