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U.S. Department of Health and Human Services

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Enforcement Actions

Kent Feeds, Inc. 25-Nov-03

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 80 Street
Lenexa, Kansas 66214-3340
Telephone: (913) 752-2100



November 25, 2003

CERTIFIED RETURN RECEIPT REQUESTED
WARNING LETTER

Ref: KAN 2004-01

Rich Dwyer, President
Kent Feeds, Inc.
1600 Oregon Street
P.O. Box 749
Muscatine, Iowa 52761

Dear Mr. Dwyer:

An inspection by a Food and Drug Administration investigator was made of your medicated feed mill located at 2901 West Arrow, Highway 20 West Box 430, Marshall, Missouri. This inspection was conducted on September 16-17, 2003 and documented significant deviations from Current Good Manufacturing Practice (CGMP) Regulations for Medicated Feeds (21 CFR, Part 225). Such deviations cause the medicated feeds being manufactured at this facility to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (Act).

Our investigation found a failure to perform and document follow-up investigations on reports of out-of-tolerance drug assays, and to take corrective measures including provisions for discontinuing distribution until control procedures have been instituted, as required by 21 CFR 225.58.

The above is not intended to be an all-inclusive list of violations. As a manufacturer of medicated and non-medicated feeds, you are responsible for assuring that your overall operation and the products you manufacture are in compliance with the law. At the conclusion of the inspection Form FDA 483, Inspectional Observations, was issued to and discussed with Donald G. Nichols, Production Superintendent. This form is a comprehensive listing of deviations observed by the investigator during the inspection.

You should take prompt action to correct the noted violations, and you should establish procedures 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, injunction, and/or notice of opportunity for a hearing on a proposal to withdraw approval of your Medicated Feed Mill License, under Section 512(m)(4)(B)(ii) of the Act and 21 CFR 514.115(c)(2). Based on the results of the September 16-17, 2003 inspection, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of medicated feeds are inadequate to assure and preserve the identity, strength, quality, and purity of the new animal drugs therein. This letter notifies you of our findings and provides you an opportunity to correct the above deficiencies.

It is necessary for you to take action on this matter now. Please let this office know in writing within fifteen (15) working days from the date you received this letter what steps you are taking to correct the problems. We also ask that you explain how you plan to
prevent this from happening again.

Your reply should be sent to Joseph G. Kramer, Compliance Officer, at the above address.

Sincerely,
/s/
Charles W. Sedgwick
District Director
Kansas City District