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FDA Warning Letter SEA 02-06

http://www.fda.gov/foi/warning_letters/g1922d.pdfv
WARNING LETTER

OCTOBER 24, 2001

In reply refer to Warning Letter SEA 02-06

Kenneth Roy Tufly, Owner Dixon Feeds, Inc. HC 77 Box 93 Dixon, Montona 59831

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Dear Mr. Tufly,

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found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed...

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1. Our investigation found a failure to separate the receipt, processing, and storage of the product containing prohibited material from non-prohibited material; failure to establish a written system, to avoid commingling and cross-contamination of common equipment; failure to maintain records sufficient to track the materials throughout the receipt, processing, and distribution of your products.

2. Our investigation found a failure to label your product with the required cautionary statements. "DO NOT FEED TO CATTLE OR OTHER RUMINANTS". The FDA suggests the statement be distinguished by different type size or color or other means of highlighting the statement so that it is easily noticed by a purchaser. In addition the other animal feeds manufactured by your firm contain NO labeling, including the "DO NOT FEED TO CATTLE OR OTHER RUMINANTS", or ingredient statements, firm name, address or other required information. This becomes even more critical since customers can pick up products, which are unlabeled, without anyone present at the firm. According to the information you provided to our investigator, customers fill out the invoice and leave a check. In at least one case you did not know the customer and were unable to locate him through local telephone directories. Since the products picked up by the customers are unlabeled and the instructions are for them to label the products, the probability of them making an error or not labeling the products is high.

In addition to the BSE problems noted above, our investigator also found deviations which can be considered violations of the Good Manufacturing Practices regulations for medicated feeds...

[...]

[FDA Warning Letters Index - Search Form Results

Company Name
Date
Issued
Issuing Office
Subject
File


Adrian Elevator, Inc.
5/03/01
Minneapolis District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

Agri-Mark Farmers Co-op,
Inc.
8/16/01
Cincinnati District
Office
Animal Proteins Prohibited in Ruminant Feed/Adulterated
View File

Alaska Garden and Pet
Supply, Inc.
4/27/01
Seattle District Office
Animal Proteins Prohibited in Ruminant Feed
View File

Bryan Enterprises
2/20/01
Cincinnati District
Office
Feed Mill/Animal Proteins Prohibited in Ruminant
Feed/Adulterated
View File

Buckeye Feed Mills, Inc.
9/20/01
Cincinnati District
Office
Animal Proteins Prohibited in Ruminant
Feed/Adulterated/Misbranded
View File

Carrollton Farmers Exchange
7/12/01
Cincinnati District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

Centerburg Mill and General
Store, Inc
3/23/01
Cincinnati District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

Centerburg Mill and General
Store, Inc.
5/23/01
Cincinnati District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

Central Ohio Farmers
Cooperative, Inc.
5/24/01
Cincinnati District
Office
Animal Protein Prohibited in Ruminant Feed
View File

Champaign Landmark, Inc.
3/05/01
Cincinnati District
Office
Animal Proteins Prohibited in Ruminant Feed/Misbranded
View File

Copley Feed & Supply
8/17/01
Cincinnati District
Office
Animal Proteins Prohibited in Ruminant Feed/Adulterated
View File

Countryline Co-Op, Inc.
5/14/01
Cincinnati District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

Dixon Feeds, Inc.
10/24/01
Seattle District Office
Animal Proteins Prohibited in Ruminant Feed/Adulterated
View File

Dorset Milling
4/16/01
Cincinnati District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

Earl B. Olson Feed Mill
4/23/01
Minneapolis District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

F.W. Renner & Sons, Inc.
8/27/01
Cincinnati District
Office
Animal Proteins Prohibited in Ruminant Feed/Misbranded
View File

Faler Feed Store, Inc.
3/21/01
Cincinnati District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

Farmers Mill & Elevator
Company
3/30/01
Atlanta District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

Farnam Companies, Inc.
7/20/01
Kansas City District
Office
Animal Proteins Prohibited in Ruminant Feed/Adulterated
View File

Greeley Elevator Company
4/04/01
Denver District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

Hartville Elevator Company,
Inc.
2/22/01
Cincinnati District
Office
Feed Mill/Animal Proteins Prohibited in Ruminant
Feed/Adulterated
View File

Himmelspach, William W.
8/08/01
Seattle District Office
Animal Proteins Prohibited in Ruminant Feed
View File

Integral Fish Foods, Inc.
6/12/01
Denver District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

Jefferson Milling Company
4/16/01
Cincinnati District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

Lime Creek Ag Services, Inc.
4/25/01
Minneapolis District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

Material Resources LLC
5/04/01
Chicago District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

Material Resources, LLC
5/04/01
Chicago District
Office
Animal Protein Prohibited in Ruminant Feed
View File

Medina Landmark, Inc.
3/23/01
Cincinnati District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

Minister Farmers
Cooperative Exchange, Inc.
4/10/01
Cincinnati District
Office
Animal Proteins Prohibited in Ruminant Feed/Feed Mill
View File

Peco Foods, Inc.
2/23/01
New Orleans District
Office
CGMP Requirements for Medicated Feeds/Animal Proteins
Prohibited in Ruminant Feed
View File

Perry Coal and Feed
Company
4/16/01
Cincinnati District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

Rietdyk's Milling Company
3/05/01
Seattle District Office
Animal Proteins Prohibited in Ruminant Feed
View File

River Valley Co-Op
3/22/01
Cincinnati District
Office
Animal Proteins Prohibeted in Ruminant Feed
View File

River Valley Co-Op
5/22/01
Cincinnati District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

Round Lake Farmers Coop.
5/30/01
Minneapolis District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

Rudy, Inc.
3/22/01
Cincinnati District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

Rudy, Inc.
5/22/01
Cincinnati District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

Sandy Lake Mills
4/09/01
Philadelphia District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

Shields Feed and Supply
Company
3/07/01
New Orleans District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

Stewart's Farm Supply
3/21/01
Cincinnati District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

Superior Feeds
6/06/01
Seattle District Office
Animal Proteins Prohibited in Ruminant Feed
View File

The Hyland Co., Inc.
8/21/01
Cincinnati District
Office
Animal Proteins Prohibited in Ruminant Feed/Adulterated
View File

The Scoular Company
5/30/01
Minneapolis District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

University of Minnesota
5/10/01
Minneapolis District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

Valley Feed Mill, Inc.
5/22/01
Cincinnati District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

Wallowa County Grain
Growers, Inc.
5/17/01
Seattle District Office
Animal Proteins Prohibited in Ruminant Feed
View File

Wallowa County Grain
Growers, Inc.
5/17/01
Seattle District Office
Animal Proteins Prohibited in Ruminant Feed
View File

Western Reserve Farm
Cooperative
3/21/01
Cincinnati District
Office
Animal Protein Prohibited in Ruminant Feed
View File

Wilcox Farms, Inc.
9/14/01
Seattle District Office
Animal Proteins Prohibited in Ruminant Feed
View File

Yachere Feed, Inc.
4/09/01
Philadelphia District
Office
Animal Proteins Prohibited in Ruminant Feed
View File

Z & W Mill, Inc.
3/27/01
Denver District
Office
Animal Proteins Prohibited in Ruminant Feed
View File
]


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