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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Farmers Union Coop Business Association 22-Jan-04

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
Telephone: (913) 752-2100


January 22, 2004

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Ref: KAN #2004-04

William DeDonder, General Manager
Farmers Union Coop Business Association
705 West Mission
PO Box 218
St. Marys, Kansas 66536

Dear Mr. DeDonder:

Recently an inspection was made of your medicated feed mill operation located at 705 West Mission, St. Marys, Kansas. This inspection was conducted on August 27, 2003, by an inspector with the Kansas Department of Agriculture who documented significant deviations from Current Good Manufacturing Practice (cGMP) Regulation for Medicated Feeds (21 CFR Part 225). Such deviations cause the medicated feeds manufactured at this facility to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

Deviations from cGMPs include:

1) You used [redacted] category II drug, but no records of the required assays were produced. Collecting and assaying at least three representative samples of medicated feed containing each drug or drug combination at periodic intervals during the calendar year is required by 21 CFR 225.52(b)(1) for feeds requiring a medicated feed mill license for their manufacture and marketing. In addition, 21 CFR 225.58(c) requires that the originals or copies of all results of assays be maintained on the premises for a period of not less than one year after distribution of the medicated feed. No such records of assays were retained for [redacted]

2) The drug [redacted] was used throughout 2003, but this drug was not included in the daily inventory record. 21 CFR 225.42(b)(7) requires you to maintain drug inventory of each lot or shipment by means of daily comparison of the actual amount of drug used with the theoretical drug usage in terms of the semi processed, intermediate and finished medicated feeds manufactured.

3) You failed to include manufacturing instructions or reference thereto in the Master Record File, as required by 21 CFR 225.102(b)(1)(iv).

4) You failed to retain medicated feed labels for one year after all the labels from that batch have been used, as required by 21 CFR 225.80(b)(2).

5) You failed to properly identify and store flush material to prevent unsafe contamination of other feeds, as required by 21 CFR 225.65(b)(2).

This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations.

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 515.22(c)(2). This letter constitutes official notification under the law and provides you with 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 problem. We also ask that you explain how you plan to prevent this from happening again. If you need more time, let us know why and when you expect to complete your correction.

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

Cc: Larry Hoobler, President Board of Director
Farmers Union Coop Business Association
1239 Sandy Land Road
Manhattan, Kansas 66502