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Food and Drug Administration Warning Letters

Food and Drug Administration Warning Letters


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Cincinnati District Office Central Region 6751 Steger Drive Cincinnati, OH 45237-3097 Telephone: (513) 679-2700 FAX: (513) 679-2771

WARNING LETTER

WL-CIN-9475-01 August 21, 2001< p>HAND DELIVERY REOUESTED

Barbara J. Hinton, President The Hyland Co., Inc. P.O. Box 29 Ashland, KY 41105-0029

Dear Ms. Hinton:

>From 7/24-27/2001 representatives from the Food and Drug Administration (FDA) and the State of Kentucky conducted an inspection of your feed mill. The inspection found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 -Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE).

The inspection found your firm failed to label feeds that contain, or may contain, prohibited materials with the required cautionary statement "Do not feed to Cattle or Other Ruminants". We suggest this statement be distinguished by different type size or color or other means of highlighting the statement so it is easily noticed by the purchaser.

Your procedures for cleaning out and/or flushing equipment after mixing feeds containing prohibited material are not adequate to prevent the cross-contamination of feeds not formulated to contain prohibited material.

You should establish adequate procedures and verify that the flush/clean-out method you use cleans out the remainder of preceding batches containing prohibited materials. Note: If you flush with feed ingredients, or sequence with non-ruminant feed, you must also label these products with the required cautionary statement "Do not feed to Cattle or Other Ruminants".

The deviations from regulations as noted above cause products being manufactured and distributed by your facility to be adulterated within the meaning of Section 402(a)(4) and misbranded within the meaning of Section 403(0 of the Federal Food, Drug, and Cosmetic Act (the Act).

This letter is not intended to be an all-inclusive list of deficiencies at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law. We have enclosed a copy

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http://www.fda.gov/foi/warning_letters/g1650d.pdf

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Cincinnati District Office Central Region 675t Steger Drive Cincinnati, OH 45237-3097 Telephone: (513) 679-2700 FAX: (513) 679-2771

WARNING LETTER

WL-CIN-8748-01

CERTIFIED MAIL RETURN RECEIPT REQUESTED

August 17, 2001

Mark W. Roesner, Owner/President Copley Feed & Supply 1468 S. Cleveland Massilion Road CopIcy, OH 44321

Dear Mr. Roesner:

On 6/19,21/2001 a Food and Drug Administration investigator conducted an inspection of your medicated feed mill located at 1468 S. Cleveland Massilion Road, Copley, OH. The inspection revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Our inspection found your firm failed to label feeds that contain, or may contain, prohibited materials with the required cautionary statement "Do not feed to Cattle or Other Ruminants"� We suggest this statement be distinguished by different type size or color or other means of highlighting the statement so it is easily noticed by the purchaser. It also revealed that your customer records are not sufficient to track the distribution of products that contain, or may contain, prohibited material The deviations from the BSE regulations, as noted above, cause products being manufactured and distributed by your facility to be adulterated within the meaning of Section 402(a)(4) and misbranded within the meaning of Section 403(f) of the Act.

This letter is not intended to be an all-inclusive list of deficiencies at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for assuring 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 violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice. Such actions include seizure and/or injunction.

[...]

http://www.fda.gov/foi/warning_letters/g1646d.pdf

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Cincinnati District Office Central Region 6751 Steger Drive Cincinnati, OH 45237-3097 Telephone: (513) 679-2700 FAX: (513) 679-2771

WARNING LETTER

WL-CIN-9099-01

CERTIFIED MAIL RETURN RECEIPT REQUESTED

August 16, 2001

Charles A. Holdten, CEO/President Agri-Mark Farmers Co-op, Inc. 813 Clark Avenue Ashland, OH 44805

Dear Mr. Holdten:

On 7/10,12-13/2001 two Food and Drug Administration investigators conducted an inspection of your medicated feed mill located at 6800 Chestnut Street, Sterling, OH. The inspection revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 -Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE).

Our inspection found your firm failed to label feeds that contain, or may contain, prohibited materials with the required cautionary statement "Do not feed to Cattle or Other Ruminants". We suggest this statement be distinguished by different type size or color or other means of highlighting the statement so it is easily noticed by the purchaser.

It also revealed that your customer records are not sufficient to track the distribution of products that contain, or may contain, prohibited material

The deviations from the BSE regulations, as noted above, cause products being manufactured and distributed by your facility to 0e adulterated within the meaning of Section 402(a)(4) and misbranded within the meaning of Section 403(f) of the Act.

This letter is not intended to be an all.inclusive list of deficiencies at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for assuring 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 coneet these violations, and you should establish a system whereby violations do not recur. Failure to promptly correct these violations may result in regulatory action, such as seizure and/or injunction, without further notice.

Our investigators also found that you mixed and distributed a cattle feed containing Lincomycin, a drug not indicated for use in cattle. Further, you did not flush the mixer, storage bins, and bulk truck used in the manufacture of the feed containing Lincomycin. The failure to adequately flush this equipment immediately following this feed caused the subsequent cross-contamination of the cattle feed, dairy cow feed and calf feeds that were handled in this equipment after the original product. You should implement procedures and/or practices to prevent the recurrence of this type of violation.

You should notify this office in writing within fifteen (15) working days of the receipt of this letter of 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 CGMP violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.

Your response should be directed to Stephen J. Rabe, Compliance Officer at the address listed above.

District Director Cincinnati District

Attachment: Small Entity Compliance Guide

Cc: Scott A. Crossen, Branch Manager Agri-Mark Farmers Co-op, Inc. 6800 Chestnut Street Sterling, OH 44276

http://www.fda.gov/foi/warning_letters/g1645d.pdf


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