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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Central Missouri Agri-Service LLC 15-Dec-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 80th Street
Lenexa, Kansas 66214-3340
Telephone: (913)752-2100


December 15,2003

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER
Ref. KAN 2004-03

John M. Fletcher, General Manager
Central Missouri Agri-Service LLC
211 North Lyon
Marshall, Missouri 65340

Dear Mr. Fetcher:

Recently an inspection was made of your medicated feed mill operation located at 465 West Marion Street, Marshall, Missouri. This inspection was conducted on September 18-19, 2003 and documented significant deviations from Current Good Manufacturing Practice (CGMP) regulations for Medicated Feeds (Title 21, Code of Federal Regulations (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).

Our investigation found a failure to perform and document follow-up investigations on reports of out of tolerance drug assays (21 CFR § 225.58) and failure to maintain the building in a reasonably clean and orderly manner (21 CFR § 225.20). These observations were also noted during previous inspections of your firm conducted in January 1997 and July 1998. At the conclusion of the inspection, a Form FDA 483, Inspectional Observations was issued to and discussed with Donald Wayne Stark, Location Manager. In addition to the FDA 483 observations, the investigator also discussed the following observations with Mr. Stark:

• Use of an expired drug ingredient [redacted] in the manufacture of [redacted] batches of medicated feed [2l CFR § 225.42(b)(3)].

• Two of three drug ingredients weighed during the inspection were slightly different weights than the amounts documented on their inventory form {21 CFR § 225.42(b)(6)].

• Wrong expiration date recorded on the inventory form for [redacted](21 CFR § 225.42 (b)(6)].

• Review of three days of batch production records revealed that one day's records did not have a responsible person's signature indicating that the records had been reviewed [redacted] 21 CFR § 225.102(b)(4)]. This observation was also noted during FDA's July 1998 inspection of your firm.

The above is not intended to be an all-inclusive list of violations. As a manufacture 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.

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, injunct9ion, and/or notice of opportunity for a hearing on a proposal to withdraw approval of yo9ur Medicated Feed Mill License, under section 512(m)(4)(B)(ii) of the Act and 21 CFR § 514.115(c)(2). (This letter constitutes official notification under the law.) Based on the results of the September 18-19, 2003 inspection, evaluated together with the evidence before FDA when the Medicated Feed Mill License was approved, the methods used in your 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 receive this letter of the steps you are taking to correct these violations. We also ask that you explain how you plan to prevent their recurrence. If you need more time, please explain the reasons for the delay and when you expect to complete your corrections.

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