Muxlow Dairy 6/10/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Detroit District|
300 River Place
Detroit, MI 48207
June 10, 2013
David A. Muxlow, Partner
8645 Wilcox Road
Brown City, Michigan 48416
Dear Mr. Muxlow:
On January 24, January 29, and February 5, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 8645 Wilcox Road, Brown City, Michigan. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) found during our investigation of your operation. You can find the FD&C 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 FD&C 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 FD&C Act, 21 U.S.C. 360(b). Further, under section 402(a)(4) of the FD&C 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 August 27, 2012, you sold a dairy cow with back tag (b)(4), house tag (b)(4), and retain tag (b)(4), for slaughter as food. On or about August 28, 2013, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of amikacin in the kidney. FDA has not established a tolerance for residues of amikacin in the uncooked edible tissue of cattle. The presence of this drug in edible tissue from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C 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 FD&C Act, 21 U.S.C. § 342(a)(4).
We also found that you adulterated the new animal drugs RVX Suppressor ANADA 200-308 (flunixin meglumine), FluMeglumine ANADA 200-308 (flunixin meglumine) and Ceftiflex ANADA 200-420 (ceftiofur sodium). Specifically, our investigation revealed that you did not use RXV Suppressor, FluMeglumine, and Ceftiflex as directed by the approved labeling. Use of these drugs in this manner is an extralabel use. See Title 21, Code of Federal Regulations (C.F.R.), Section 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 FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C 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 RVX Suppressor and FluMeglumine to your dairy cows without following the withdrawal period and duration of treatment as stated in the approved labeling. In addition, our investigation found that you administered Ceftiflex to cows identified with ear tag numbers (b)(4) and (b)(4) without following the withdrawal period as stated in the approved labeling. Your extralabel use of RVX Suppressor, FluMeglumine and Ceftiflex was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your use of these drugs was 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 FD&C Act, 21 U.S.C. 360b(a), and adulterated with the meaning of section 501(a)(5) of the FD&C 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.
We acknowledge receipt of your written response dated February 18, 2013 regarding the Form FDA 483 Inspectional Observations issued to you at the close of the above inspection. Your response states that you have changed the way you record treatments including, recording the number and dose administered. Additionally, you state that you are now paying better attention to the expiration dates on medicines. We acknowledge the example medication record provided; however, it appears inadequate as it does not address the observation 1, 2, 3 and 5. For example ensuring the medicated animal is not released within the withdrawal time as indicated on the approved label.
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 LCDR Kelli Wilkinson, Compliance Officer, U.S. Food and Drug Administration at 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions about this letter, please contact LCDR Wilkinson at 313-393-8120.
Glenn T. Bass
Detroit District Office
Daniel E. Muxlow, Partner
Leigh A. Muxlow, Partner