Inspections, Compliance, Enforcement, and Criminal Investigations
Anamax Corporation 09-Jun-05
Department of Health and Human Services
Public Health Service
Minneapolis District Office
June 9, 2005
RETURN RECEIPT REQUESTED
Refer to MIN 05-15
Michael J. Langenhorst
P.O. Box 10067
Green Bay, WI 54307
Dear Mr. Langenhorst:
Our inspection of your rendering plant located at 505 Hardman Avenue South, South St. Paul, Minnesota, from January 12-20, 2005, revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations , Part 589 .2000 (21 CFR 589.2000), Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Because you failed to follow the requirements of this regulation, products being manufactured and distributed by your facility are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(4)], and misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)].
Our investigation found that you failed to provide for measures to prevent commingling or cross-contamination and to maintain sufficient written procedures [21 CFR 589.2000(e)] in that:
1. You failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues into feeds that may be used for ruminants.
2. You failed to maintain written procedures specifying the clean-out procedures or other means to prevent carryover of protein derived from mammalian tissues into feeds that may be used for ruminants.
Our investigation also found that you failed to label products that may contain protein derived from mammalian tissues with the statement, "Do not feed to cattle or other ruminants." For example, your Feather Meal and Stabilized Poultry By-Product Meal lack this statement, even though the absence of sufficient measures to avoid commingling or cross-contamination may result in these products containing protein derived from mammalian tissues. Because your products do not bear this caution statement, they are misbranded under Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)).
The above is not intended as an all-inclusive list of violations. 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.
You should acknowledge this letter within 15 working days of receiving and include any additional corrective actions concerning your facility. We have received your letter dated January 31, 2005, which replies to the Form FDA-483 issued on January 20, 2005, and your letter dated February 25, 2005, that states all corrections have been implemented. The corrections you have reported appear to be adequate but will be evaluated further during our follow-up inspection.
Your response should be directed to Compliance Officer Jane E. Nelson at the address on the letterhead. If you have any questions regarding this letter, you may phone Ms. Nelson at (612) 758-7119.
W. Charles Becoat