Inspections, Compliance, Enforcement, and Criminal Investigations
Kent Feeds, Inc. 25-Nov-03
Department of Health and Human Services
Public Health Service
Kansas City District
November 25, 2003
CERTIFIED RETURN RECEIPT REQUESTED
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
Charles W. Sedgwick
Kansas City District