Inspections, Compliance, Enforcement, and Criminal Investigations
Finlayson Ag Center 08-Nov-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
240 Hennepin Avenue
Minneapolis MN 55401 -1999
November 8, 2001
RETURN RECEIPT REQUESTED Refer to MIN 02-14
Gregory M. Sostak
Finlayson Ag Center
6476 Broadway Street
Finlayson, Minnesota 55735
Dear Mr. Sostak:
The Food and Drug Administration (FDA) conducted an inspection of your facility located at 6476 Broadway Street, Finlayson, MN, on October 15, 2001. During the inspection the FDA investigator documented deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000, "Animal Proteins Prohibited in Ruminant Feed" (21 CFR 589.2000). The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations cause products being manufactured and/or distributed by this facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act).
Our investigation found a failure to provide adequate measures to avoid commingling or cross-contamination of non-prohibited materials. For example, the common scoop used to transfer prohibited material from 50-pound bags to smaller brown bags is not cleaned between prohibited and non-prohibited material uses.
Also, opened bags of prohibited materials were reported to be stored next to other open feed ingredient bags.
The above is not intended to be an all-inclusive list of deviations from the regulations. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring that your overall operation and the products you manufacture and distribute are in compliance with the law. We have enclosed a copy of the FDA?s Small Entity Compliance Guide to assist you with complying with the regulation.
You should take prompt action to correct these violations and you should establish a system whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory and/or administrative sanctions. These sanctions include, but are not limited to, seizure and/or injunction.
Please provide this office a written update within15 working days of receipt of this letter with the steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step ?being taken to correct the violations and prevent their recurrence. If corrective action cannot be taken within 15 working days, state the reason for the delay and the date by 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 Compliance Officer Timothy G. Philips at the address indicated on the letterhead.Sincerely,
David R. Yost