Inspections, Compliance, Enforcement, and Criminal Investigations
Meadow Wood Animal Clinic 01-Feb-07
Department of Health and Human Services
Public Health Service
Now England District
VIA FEDERAL EXPRESS
February 1, 2007
Dr. Michael A. Wing
Meadow Wood Animal Clinic
6 Wing Lane
Cornville, ME 04976
Dear Dr. Wing:
On October 24 and November 6, 2006 an investigator from the U.S. Food and Drug Administration (FDA) conducted an investigation involving the use of drugs in your veterinary practice. That investigation revealed that you caused animal drugs to be unsafe under Section 512(a) [21 U.S.C. § 360(b)(a)] of the Federal Food, Drug, and Cosmetic Act (the Act) and adulterated within the meaning of Section 501(a)(5) [21 U.S.C. § 351 (a)(5)] of the Act because the drugs were used in a manner that did not conform with their approved applications. Additionally, your actions resulted in two animals for sale for slaughter as food being adulterated within the meaning of section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(n)] of the Act.
The investigation revealed that you prescribed [redacted] to treat his dairy cows. As described in more detail below, you failed to, among other things, establish a suitable withdrawal period. On or about August 15, 2006, [redacted] delivered a medicated animal, a dairy cow, for slaughter as human food. The cow was purchased by a buyer the same day and was slaughtered for human food on August 16, 2006, at [redacted]. The United States Department of Agriculture, Food Safety and Inspection (USDA/FSIS) reported the presence of [redacted] 3.372 ppm (parts per million) in the liver of this dairy cow (USDA sample 468279). A tolerance of 0.125 ppm [redacted] the liver of cattle has been established for residues, Title 21, Code of Federal Regulations. Part 556.286 (21 C.F.R. 566.296). The presence of [redacted] levels above the established tolerance in the edible tissues of the animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] of the Act.
You prescribed the drugs be [redacted] be used in an extralabel manner by [redacted]. For example, you prescribed the [redacted] as an [redacted] injection once a day up to seven days, whereas it is approved for [redacted] injection for up to three days. You also prescribed [redacted] to lactating dairy cows over 20 months of age. This is contrary to product's labeling, which says not to use it in dairy cattle 20 months of age or older. The extralabel use of approved veterinary or human drugs in animals is permitted only if it complies with sections 512(a)(4) [21 U.S.C. § 360(b)(a)(4)] and 512(a)(5) [21 U.S.C. § 360b(a)(5)] of the Act and the regulations for Extralabel! Drug Use in Animals, Title 21, Code of Federal Regulations, Part 530 (21 C.F.R. Part 530). Our investigation found that you failed to comply with these requirements in that, for example, you did not:
(i) Establish a substantially extended withdrawal period prior to marketing of milk, meat, eggs, or other edible products supported by appropriate scientific information if applicable;
(ii). institute procedures to assure that the identity of the treated animal or animals is carefully maintained; and
(iii) Take appropriate measures to assure that no illegal drug residues occur in any food-producing animal subjected to extralabel treatment.
The above is not intended to be an ail-inclusive list of violations. As licensed veterinarians, you are responsible for complying with the requirements of the Act, including the extralabel use regulations promulgated under the Act. You should take prompt action to correct the above violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice, such as injunction.
We have enclosed a copy of 21 C.F.R. 530 for your reference. We strongly suggest that you review 21 C.F.R. 530 and become familiar with all of its requirements so that you can prevent future violations of the Act. This includes establishing substantially extended withdrawal periods supported by appropriate scientific information to the owners of any dairy cattle for which you or your practice prescribe, or have prescribed, the extralabel use of flunixin and other new animal drugs so that additional illegal drug residues can be avoided.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within 15 working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct these violations and prevent their recurrence. If corrective actions cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the and prevent their recurrence. If corrective actions cannot be completed within fifteen (15) working days, 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 reply should be directed to Anthony P. Costello, Compliance Officer, 1 Montvale Avenue, Stoneham, MA 02180. If you have any questions about this letter you can contact Mr. Costelio at 781596-7716.
Gail T. Costello
New England District Office
Julie A. Cornett D.V.M.
Senior Veterinary Officer
Technical Service Center
1299 Farnam Street
Omaha, NE 68102
State of Maine
State Board of Veterinary Medicine
Office of Licensing and Registration
35 State House Station
Augusta, ME 04333-0035