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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Farmers Market of Bolivar, Missouri, Inc. 10-Jul-07

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


July 10, 2007

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER
Ref. KAN 2007-09

John A. Rickman, President
Farmers Market of Bolivar, Missouri, Inc.
1184 East 460th Road
Bolivar, Missouri, 65613-8103

Dear Mr. Rickman:

An inspection of your medicated feed mill located at 1184 E. 460th Rd, Bolivar, Missouri conducted by a Food and Drug Administration investigator on March 13 - 15 and 20, 2007 found significant deviations from current Good Manufacturing Practice (cGMP) regulations for Medicated Feeds, Title 21 Code of Federal Regulations, Part 225. Such deviations cause medicated feeds being manufactured at this facility to be adulterated within the meaning of Section 501(a)(2)(B) [21 U.S.C. 351(a)(2)(B)] of the Federal Food, Drug, and Cosmetic Act.

Our inspection noted the following deviations:

• A failure to document the investigations and any corrective actions taken as a result of out-of-speciation assay results. [21 CFR 225.58(d) and 21 CFR 225.58(e)]. For example, in 2006, medicated feeds pyrantel tartrate/carbadox, nicarbazin, amprolium were not within permissible assay limits and no investigation and correction action, including discontinuing distribution of the out of specification medicated feeds were taken.

• A failure to have a Master Record File for the manufacturing of all products. [21 CFR 225.102(b)]. For example, either no Master Record File existed or the file was created after the medicated feed was manufactured.

• A failure to maintain complete production record(s). [21 CFR 225.102(b)(2)(i) - (i v). For example, the production records often failed to identify that the feed was a medicated feed.

The above is not intended as an all-inclusive list of cGMP violations. As a manufacturer of medicated and non-medicated feeds, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law.

You should take prompt action to correct these cGMP violations, and you should-establish procedures whereby such violations do not recur. Failure to promptly correct these cGMP violations may result in regulatory and/or administration sanction. 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) [21 U.S.C. 360b(m)(4)(B)(ii) of the Act and 21 CFR 515.22(c)(2). Based on the results of the March 2007 inspection, evaluated together with the evidence before FDA when the Medicated Feed Mill License was approved, 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 finding and provides you an opportunity to correct the above deficiencies.

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 taken to correct the cGMP violations and prevent their recurrence. If corrective action cannot be completed within fifteen (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 made to Ralph J. Gray, Compliance Officer, Compliance Branch at 11630 West 80th Street, Lenexa, KS 66214. If there is any question about this letter, please call this office at (913) 752-2110.

Sincerely

/S/

John W. Thorksy
District Director
Kansas City District

cc: Mr. Arvil Krueger, Vice President
Farmers Market of Bolivar, Missouri, Inc.
1184 East 460th Road
Bolivar, Missouri, 65613-8103

Tony. L. Claxton, Program Coordinator
Bureau of Feed and Seed
Missouri Department of Agriculture
P.O. Box 630
Jefferson City, MO 65102-630