Inspections, Compliance, Enforcement, and Criminal Investigations
Pomeroy, Ed M. 04-May-06
Department of Health and Human Services
Public Health Service
May 4, 2006
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 06-27
Ed M. Pomeroy
7304 Vista Drive
Ferndale, WA 98248
Dear Mr. Pomeroy:
An investigation at your dairy operation, located at 2343 Willeys Lake Road, Custer, Washington, conducted by a representative of the U.S. Food and Drug Administration (FDA) on October 18, 2005, and December 5, 2005, revealed that you caused the new animal drug, Neomycin 325 (Neomycin Sulfate powder packet), and the medicated feed, "Instant Amplifier Max MT Medicated" milk replacer (containing neomycin), to become adulterated within the meaning of sections 501(a)(5) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 351(a)(5)] and 501(a)(6) of the Act [21 U.S.C. 351(a)(6)], and unsafe under section 512 of the Act [21 U.S.C 360b]. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov
Our investigation determined that on August 12, 2005, and August 26, 2005, you delivered calves to[redacted] a livestock collector, who subsequently tagged the animal with back tags #1007 and #0818, respectively, and delivered the calves to [redacted] on the same dates. The calf with back tags #1007 and #0818, identified on USDA Case #05-0652-WA and further identified on USDA-FSIS lab reports #217272 and #217273, respectively, were delivered for slaughter as human food to [redacted] by [redacted], also on August 12, 2005, and August 26, 2005, respectively. USDA analysis of tissue samples collected from the calves identified the presence of neomycin in the kidney at detectable levels in the calf with back tag #1007 tissue, and at 5.41 ppm in the calf with back tag #0818.
A subsequent investigation revealed that you adulterated the drug, Neomycin 325, within the meaning of section 501(a)(5) of the Act [21 U.S.C. 351 (a)(5)] when you used it in a calf to be processed for veal, which is contrary to the warning on the label. Specifically, you administered the drug, Neomycin 325, by adding it to Instant Amplifier Max NT Medicated Dairy Herd & Beef Calf Milk Replacer, the liquid milk replacer supplement that you feed your calves, contrary to the directions set forth in the approved labeling that clearly state that it is not for use in liquid supplements and contrary to the label statement that it is not to be used in calves to be processed for veal.
Because the Act does not permit the extralabel use of drugs in or on medicated feeds, your actions cause the neomycin 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).
You also caused the adulteration of an animal feed bearing or containing a new animal drug under section 501(a)(6) of the Act [21 U.S .C. 351(a)(6)} when you failed to use the milk replacer in conformance with its approved labeling by feeding it to calves to be processed for veal and by adding the drug neomycin to it.
The above is not intended to be an all-inclusive list of violations. 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 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, 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.
Please send your written reply to the Food and Drug Administration, Attention: Michael J . Donovan, Compliance Officer, 22201 23'd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Mr. Donovan at (425) 483-4906.
Charles M. Breen