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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Kalmbach Feeds, Inc. 16-May-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-277



May 16, 2006

FedEx

WARNING LETTER
CIN-06-29538-13

Paul M. Kalmbach,
President and Owner
Kalmbach Feeds, Inc.
7148 State Highway 199
Upper Sandusky, OH 43351-9346

Dear Mr. Kalmbach:

An inspection of your licensed medicated feed mill, located at the above address, conducted by Food and Drug Administration investigators on March 2-9, 2006 found significant violations of the Federal Food, Drug, and Cosmetic Act (the Act). Your firm uses the new animal drug Coban 60 (a Type A medicated article) in an extralabel manner. The extralabel use of a new animal drug in or on animal feed is prohibited by section 512(a)(4)(A) of the Act and Title 21, Code of Federal Regulations, Part 530.11(b) (21 C.F.R. 530.11(b)). The extralabel use of Coban 60 to produce feed for cattle causes the new animal drug to be deemed unsafe within the meaning of section 512(a)(1) [21 U.S.C. § 360b(a)(1)] of the Act and adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act. In addition, the use of Coban 60 to produce medicated feed for cattle causes the medicated feed to be unsafe under section 512(a)(2) [21 U.S.C. § 360b(a)(2)] of the Act and adulterated under section 501(a)(6) [21 U.S.C. § 351(a)(6)] of the Act.

Your firm also fails to conduct potency assays on at least three representative samples of each feed required to be manufactured by a licensed feed mill at periodic intervals during the calendar year in violation of 21 CFR 225.58(b)(1). This failure to comply with current good manufacturing practice requirements causes 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 Act.

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 ensuring 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 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) [21 U.S.C. § 360b(m)(4)(B)(ii)] of the Act and 21 CFR 515.22(c)(2). This letter constitutes official notice under the law.

Based on the results of the March 2-9, 2006, 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.

You should notify this office, in writing, within fifteen (15) working days of receiving 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 being taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 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 directed to Charles S. Price, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237-3097. If you have any questions regarding this letter, you may call Mr. Price at (513) 679-2700 extension 165.

Sincerely,

/S/


Carol A. Heppe,
District Director
Cincinnati District