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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Gold Eagle Cooperative 21-Dec-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Kansas City District
Southwest Region
11630 West 80th Street
Lenexa, Kansas 66214-3340



December 21, 2005

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

Ref. KAN 2006-08

Mr. Paul Rasmussen, President
Gold Eagle Cooperative Board of Directors
1145 Birch Ave
Corwith, IA 50430

Dear Mr. Rasmussen:

An investigator from our office conducted two inspections of your animal feed manufacturing operations at 415 N. Locust St., Goldfield, Iowa on August 23 and August 25 -26, 2005. During these inspections, a significant deviation from the requirements set forth in Title 21, Code of Federal Regulations (CFR), Part 589 .2000 [21 CFR 589 .2000] - Animal Proteins Prohibited in Ruminant Feed, was identified . The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Our investigation found a failure to label one of your products, "ISLACT - IS LACTATION," a swine feed, with the statement "Do Not Feed to Cattle or Other Ruminants," as required by 21 CFR 589 .2000(d) . Although your swine feed is not formulated with protein derived from mammalian tissues as defined in 21 CFR 589 .2000(a)(1), which is prohibited in ruminant feed, your production practices may cause the finished product to contain such material. Our investigator found that your firm does not have a strategy for sequencing feeds and does not flush or otherwise clean shared production equipment between the manufacture of poultry feed formulated with protein derived from mammalian tissues and swine feed formulated without such material . As a result, swine feed may acquire protein derived from mammalian tissue from poultry feed residue remaining on the shared production equipment. Your failure to label your "ISLACT - IS LACTATION" swine feed with the statement "Do Not Feed to Cattle or Other Ruminants" causes it to be misbranded under section 403(a)(1) of the Act.

The above is not intended to be an all-inclusive list of deficiencies at your facility. As a manufacturer of animal feed, you are responsible for ensuring that your overall operation and the products you manufacture and distribute comply with the law.

You should take prompt action to correct this violation and establish a system whereby such violations do not recur. Failure to promptly correct this violation may result in regulatory action, such as seizure and/or injunction, without further notice.

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 an explanation of each step being taken to correct the violation and prevent its recurrence. If corrective action cannot be completed within fifteen (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.

Please send your reply to the Food and Drug Administration, Attention: Ralph Gray, Compliance Officer, 11630 West 80th Street, Lenexa, KS 66214-3340.

Sincerely,
/s/

C.R. Pendleton for John W. Thorsky
District Director
Kansas City District