Inspections, Compliance, Enforcement, and Criminal Investigations
Endsley Dairy Farm, LLC 01/05/2009
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
300 River Place
Detroit, MI 48207
RETURN RECEIPT REQUESTED
January 5, 2009
Mr. Paul E. Endsley, President
Endsley Dairy Farm, LLC
5311 Bayne Road
Hastings, Michigan 49058
Dear Mr. Endsley,
On August 28 and September 3, 2008, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 5311 Bayne Road, Michigan 49058. 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 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 May 20, 2008, you sold a dairy cow, identified with ear tag (b)(4) for slaughter as food. On May 22, 2008, (b)(4), slaughtered this animal. United Sates Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal detected the presence of gentamicin in the kidney. There is no allowable tolerance for gentamicin in cattle. The presence of gentamicin in this animal 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).
We also found that you adulterated the new animal drug, gentamicin. Specifically, our investigation revealed that you did not use gentamicin as directed by its approved labeling. Use of this drug in this manner is an extralabel use, Title 21, Code of Federal Regulations 530.3(a) (21 C.F.R. 530.3(a)).
The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the 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 gentamicin to a dairy cow without following the animal class as stated in the approved labeling. Your extralabel use of gentamicin 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 this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug 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).
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 directed to Judith A. Jankowski, 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 Judith A. Jankowski at 313-393-8125; fax 313-393-8139; email firstname.lastname@example.org.
Joann M. Givens